BioRePeel
Also known as: biorepeel, bio re peel, biorepeel cl3
BioRePeelCl3 FND is a branded, two-phase professional peel marketed by CMed Aesthetics as a topical medical device containing 35% trichloroacetic acid. No peer-reviewed clinical trial of the product was located, so its efficacy, penetration depth and product-specific adverse-event profile remain unestablished.
Evidence status
Manufacturer-supported
No peer-reviewed or registered clinical study of BioRePeel was located as of 1 August 2026; its only peer-reviewed mention is an unreferenced author anecdote in a narrative review. Composition, two-phase mechanism and tolerability are documented only in CMed and distributor material, while independent evidence for conventional 35% TCA describes medium-depth peeling, desquamation and reduced tolerability. Those conventional-TCA findings cannot be transferred to the branded formulation, leaving product-specific efficacy and safety evidence absent.
What BioRePeel is, and what is disclosed#
BioRePeelCl3 FND is a named CMed Aesthetics product, not a generic peel category. The manufacturer describes it as a two-phase topical medical device for the face, neck and décolleté and states that each box contains five 6 mL ampoules. Its disclosed active headline is 35% trichloroacetic acid (TCA), accompanied by unnamed and unquantified alpha-, beta- and poly-hydroxy acids, amino acids, vitamins and GABA.[2]BioRePeelCl3 FND is stated by its manufacturer to contain 35% trichloroacetic acid together with an unquantified mixture of alpha-hydroxy acids, beta-hydroxy acids, poly-hydroxy acids, amino acids, vitamins and GABA, supplied as five 6 mL ampoules per box.Directly tested by the source[2] CMed Aesthetics. BioRePeelCl3 FND [manufacturer product page]. Accessed 1 August 2026.Tier 4[2]CMed publishes no concentration for any ingredient other than the 35% TCA and names none of the alpha-, beta- or poly-hydroxy acids, amino acids or vitamins on its own product page. The only named co-ingredient anywhere in the supply chain comes from a UK distributor, which states the TCA is 'buffered with Arginine' — unquantified, and not corroborated by the manufacturer. Without quantities or a pH, the formulation cannot be independently assessed, replicated or compared with any other peel.Directly tested by the source[2] CMed Aesthetics. BioRePeelCl3 FND [manufacturer product page]. Accessed 1 August 2026.Tier 4
No concentration other than TCA, complete named ingredient list, pH or buffering capacity is published on the manufacturer page examined. A distributor says the TCA is buffered with arginine, but the manufacturer source does not corroborate or quantify that statement.[2, 13] The formulation therefore cannot be assessed from headline percentage alone.
“Biphasic” refers to hydrophilic and lipophilic phases. CMed describes the associated patent as a preparation and preservation system, and its protocol sheet calls the shaken product a temporary emulsion. A formulation patent does not demonstrate clinical benefit or control of penetration depth.[3, 4]The 'biphasic' or 'two-phase' descriptor traces to a patent CMed Aesthetics describes as a 'Preparing and preservation system for topical products with hydrophilic and lipophilic phases' — that is, a formulation and stability patent, and the manufacturer's own protocol calls the shaken product a 'temporary emulsion'.Directly tested by the source[3] CMed Aesthetics. About Us [manufacturer corporate page]. Accessed 1 August 2026.Tier 4[4] CMed Aesthetics. BioRePeelCl3 protocol of use [product documentation PDF, hosted by the Spanish distributor]. Accessed 1 August 2026.Tier 4
The manufacturer’s stated intended use is on healthy skin as an adjunct in preventing acne and its scarring outcomes.[2] Broader claims for melasma, pigmentation, photoageing or general rejuvenation need their own support rather than being inferred from the brand name or from generic TCA literature.
Use of BioRePeel in aesthetic practice#
BioRePeel should be treated as a professional 35% TCA preparation whose lawful supply, intended purpose, full instructions and practitioner requirements must be verified for the country and premises concerned. Medical-device status is a regulatory route, not evidence that the product outperforms another peel.
The only peer-reviewed mention located is one unreferenced sentence in a narrative review, where the authors say from experience that combining BioRePeel with microneedling gives better results. It supplies no patient numbers, comparator, outcomes or adverse-event data. It cannot support efficacy, combination treatment or safety.[1]The only mention of BioRePeel anywhere in the peer-reviewed literature is a single unreferenced sentence of author opinion inside a narrative review of acne-scar treatments, reporting that combining it with microneedling 'gives much better results' — with no patient numbers, outcome measure, comparator or adverse-event data.Directly tested by the source[1] Chilicka K, Rusztowicz M, Szyguła R, Nowicka D. Methods for the Improvement of Acne Scars Used in Dermatology and Cosmetology: A Review. Journal of Clinical Medicine. 2022;11(10):2744.Tier 4
The manufacturer-derived one-page protocol gives preparation, contact and removal directions but no contraindication list, complication plan, Fitzpatrick-specific information or cited evidence. The current complete instructions for use and appropriately governed training requirements govern treatment.[4]The manufacturer-derived one-page protocol gives preparation, contact and removal directions but no contraindication list, complication plan, Fitzpatrick-specific information or cited evidence; the current complete instructions for use govern treatment.Directly tested by the source[4] CMed Aesthetics. BioRePeelCl3 protocol of use [product documentation PDF, hosted by the Spanish distributor]. Accessed 1 August 2026.Tier 4
In Great Britain, a device placed on the market must follow the applicable UKCA or accepted CE route and be registered with the MHRA; a non-UK manufacturer needs a UK Responsible Person.[12] BioRePeel’s registration entry, device class, notified-body details and conformity certificate were not verified from the public material examined. Unconfirmed must not be rewritten as absent.[no source found]We could not verify BioRePeel's MHRA device registration: the Public Access Registration Database is a JavaScript application that could not be queried programmatically, so registration is unconfirmed rather than absent.We looked and found no source either way
Contraindications and cautions#
A complete, current manufacturer instructions-for-use document is essential because no product-specific published trial supplies an alternative safety framework. Distributor product pages, training-group protocols and social-media posts are not substitutes.
The manufacturer describes the intended substrate as healthy skin.[2] Active dermatitis, infection, broken or significantly inflamed skin, an unexplained lesion, recent adverse reaction or any condition excluded by the current instructions should stop treatment or trigger medical assessment.
Thirty-five per cent TCA sits at the lower end of the concentration range that the 2023 English consultation associated with medium-depth peels, although both that document and JCCP define depth by tissue injury rather than concentration alone.[7, 8] BioRePeel penetration depth has not been published. It is therefore unsafe to label it “superficial” or “non-invasive” solely from marketing, and equally unsound to declare that it necessarily creates a conventional medium-depth injury.
Pigmentary risk cannot be quantified for this product because no Fitzpatrick-stratified study or adverse-event series was located. The absence of published events is not evidence of low risk.
Product use must also remain within training, insurance, premises rules and local law. England’s proposed green/amber/red framework is not in force. Chemical peels are not among the four currently listed special procedures in Wales, although Welsh Ministers have power to add procedures. Scotland has separate and evolving provisions, so current primary law and local-authority requirements need direct checking rather than inference from the England position.[7]No licensing scheme is in force in England as at 1 August 2026: the 2023 green/amber/red tiering that would have placed medium-depth peels in amber was a proposal, and the 7 August 2025 government response declined to assign individual procedures to tiers, saying further work was needed and that secondary legislation must pass first.Directly tested by the source[7] Department of Health and Social Care. Licensing of non-surgical cosmetic procedures: consultation and outcome. GOV.UK. Consultation opened 2 September 2023; outcome published 7 August 2025.Tier 1[11]Chemical peels are not licensable in Wales: Part 4 of the Public Health (Wales) Act 2017 has been in force since 29 November 2024 but section 57 lists only four special procedures — acupuncture, body piercing, electrolysis and tattooing — though Welsh Ministers hold a power to add procedures by regulations.Directly tested by the source[11] Public Health (Wales) Act 2017 (anaw 2), Part 4, section 57 ("What is a special procedure?"); Part 4 commenced 29 November 2024 by SI 2024/1248.Tier 1[7, 11, 13]iUK access is gated by suppliers rather than by national law: distributors require proof of BioRePeel-specific training plus a prior accredited chemical peel certificate, but that is a commercial term of sale. No England-wide or Wales-wide statute currently restricts who may perform a chemical peel — though local authority special treatment licensing, for example under the London Local Authorities Act 1991 and equivalent local Acts elsewhere, can impose premises and practitioner conditions in some areas, so check your own council.Inferred from adjacent evidence[7] Department of Health and Social Care. Licensing of non-surgical cosmetic procedures: consultation and outcome. GOV.UK. Consultation opened 2 September 2023; outcome published 7 August 2025.Tier 1[11] Public Health (Wales) Act 2017 (anaw 2), Part 4, section 57 ("What is a special procedure?"); Part 4 commenced 29 November 2024 by SI 2024/1248.Tier 1[13] Aesthderm (UK distributor). BioRePeelCl3 FND (5x6ml) [product listing]. Accessed 1 August 2026.Tier 4
Clinical use and the evidence behind it#
There is no peer-reviewed clinical trial of BioRePeel. No randomised trial, split-face study, cohort or case series was located, and no head-to-head comparison tests the product against conventional TCA, another peel or no treatment.[no source found]There is no head-to-head study comparing BioRePeel with a conventional TCA peel, with any other peel, or with no treatment, so its central marketing premise — same acid strength, less downtime — has never been tested against a comparator.We looked and found no source either way
The sole indexed mention is the unquantified author anecdote in a narrative acne-scar review.[1] It does not establish that BioRePeel works alone or with microneedling.
Independent evidence on conventional 35% TCA provides context, not product evidence. In a 40-woman comparative study of facial photoageing, 20 received conventional 35% TCA and 20 received 70% glycolic acid plus 15% TCA. Both groups improved measured skin parameters; the authors described 35% TCA as more effective for wrinkle reduction but less tolerable. The study was not stated to be randomised or blinded, and it did not use BioRePeel.[5]In independent clinical work, conventional aqueous 35% TCA was applied over five sessions at 14-day intervals to 20 women — one arm of a 40-patient comparative study in Glogau II-III photoageing — producing significant objective improvement in elasticity, hydration, melanin index and erythema index. The authors concluded that '35% TCA peel is more effective in reducing wrinkles, despite a lower tolerability'. They reported that the lower-strength comparison peel 'did not cause dryness, edema, or intensive lysis of the epidermis', implying the 35% arm did, and that erythema frequency rose with the higher TCA concentration. No adverse events requiring intervention or discontinuation were observed in either group.Directly tested by the source[5] Kubiak M, Mucha P, Rotsztejn H. Comparative study of 15% trichloroacetic acid peel combined with 70% glycolic acid and 35% trichloroacetic acid peel for the treatment of photodamaged facial skin in aging women. Journal of Cosmetic Dermatology. 2020;19(1):137-146.Tier 3
A separate prospective cohort treated actinic cheilitis on the lower lip with conventional 35% TCA after bilateral mental-nerve blocks. Eleven participants completed treatment; redness and swelling were the commonest effects. The therapeutic lip indication, anaesthesia, small uncontrolled design and non-BioRePeel formulation prevent read-across to routine facial use.[6]A separate independent prospective cohort applied 35% TCA to the lower lip in 11 patients with actinic cheilitis, following bilateral mental nerve blocks; redness and swelling were the commonest side effects, and the authors concluded the peel was 'safe, well-tolerated, and effective' for that indication. Read it as context for what 35% TCA involves in a clinical setting — the anaesthesia reflects a highly sensitive site and a therapeutic indication as much as the concentration — not as evidence about how BioRePeel behaves on the face.Directly tested by the source[6] Kuta V, Taylor SM. Trichloroacetic Acid as a Topical Treatment for Actinic Cheilitis. OTO Open. 2025;9(2):e70132.Tier 3
These studies show why both favourable and unfavourable conventional-TCA findings must stay attached to the tested formulations, sites and populations. Neither efficacy nor tolerability can be assigned to BioRePeel by concentration alone.
Selecting a BioRePeel product and supplier#
Selection is primarily a due-diligence exercise. Obtain and retain:
- the current full instructions for use, including contraindications and adverse-event handling;
- the conformity certificate and mark details appropriate to the market;
- device class, notified or approved body details where applicable;
- MHRA registration and UK Responsible Person details for Great Britain supply;
- supplier identity, batch traceability, storage conditions, expiry information and complaint/vigilance route;
- proof that insurance covers this named product, concentration and procedure.
The manufacturer page and distributor page examined do not publish all of those elements.[2, 13] Failure to locate them online does not prove non-compliance, but inability of the supplier to provide them is a practical disqualifier.
“Clinically proven”, “no downtime”, “medical grade” or “non-invasive” wording is not a sufficient basis for product selection. The product-specific clinical evidence is absent, “medical device” does not mean comparatively effective, and a clinic-issued handout anticipates a healing period.[12, 13, 14]
Peel depth is an observed tissue effect as well as a formulation property. The JCCP premises document classifies medium depth as full-thickness epidermal destruction into the upper dermis and imposes additional premises considerations, but it is a voluntary-register standard rather than statutory law.[8]Chemical peels sit within the JCCP/CPSA 'Chemical Peels and Skin Rejuvenation' modality, and the JCCP's premises standards impose additional physical requirements — impervious non-carpeted flooring, smooth impermeable ceilings and fittings — specifically where medium-depth peels are performed.Directly tested by the source[8] Joint Council for Cosmetic Practitioners. Work Standards for Chemical Peels and Skin Rejuvenation (CPSR) — Premises Standards 005: Clinical Peels & Skin Rejuvenation. March 2018. (The document does not bear the number 'JCCPWS 005'; it cross-refers to JCCPWS 001 Minimum Requirements as a prerequisite.)Tier 4
Adverse effects and their management#
No published BioRePeel adverse-event series was located, so product-specific rates of pain, erythema, oedema, frosting, desquamation, post-inflammatory hyperpigmentation, hypopigmentation, infection or scarring cannot be quoted.
A clinic-issued aftercare sheet anticipates healing and post-treatment restrictions. This shows that an absolute “no recovery” message is not compatible with all material circulating for the brand, but the sheet is not a manufacturer IFU and does not quantify expected reactions.[14]A BioRePeel pre- and post-peel patient handout circulated by a clinic undercuts an absolute no-downtime reading: the post-peel instructions are headed 'Until the skin is fully healed and in tact' and impose a seven-day ban on AHAs, BHAs, retinol, waxing, laser hair removal, sunbeds, swimming and saunas. Note this is clinic-issued aftercare rather than a document published by CMed itself — no manufacturer aftercare guidance could be located at all, which is its own finding.Directly tested by the source[14] BioRePeelcl3 (Blue) and FND (Gold) Pre Peel Instructions / Post Peel Instructions [patient information sheet, distributed by Dermestetics]. Accessed 1 August 2026.Tier 4
Independent conventional-TCA work reported lower tolerability at 35% than a lower-strength combination peel, with erythema increasing with the higher TCA concentration.[5] The small lower-lip cohort reported redness and swelling.[6] Those findings justify caution around the acid concentration but cannot establish BioRePeel event rates.
Unexpected severe pain, blistering, marked swelling, ulceration, infection signs, eye exposure, persistent dyspigmentation, delayed healing or scarring requires immediate cessation and escalation through the current complication pathway, manufacturer vigilance route and medical care appropriate to severity. A practitioner needs that pathway before treatment begins.
Referral and scope boundaries#
Medical assessment is appropriate when the proposed treatment area contains an undiagnosed lesion, active inflammatory dermatosis, infection, ulceration or abnormal healing, or when a complication exceeds the practitioner’s competence.
BioRePeel’s manufacturer states an adjunctive prevention indication for acne and scarring on healthy skin.[2] Diagnosing or medically managing acne, melasma, actinic damage or a scar disorder remains separate from using a device within its intended purpose.
A supplier’s training certificate is a commercial access condition, not a statutory licence or proof of clinical competence.[13] Conversely, absence of a national practitioner restriction does not remove duties under product law, local licensing, insurance, consent, premises governance and professional scope.
Great Britain, Northern Ireland, England, Wales and Scotland must not be collapsed into one “UK-approved” statement. The MHRA guidance cited here addresses Great Britain device supply and notes distinct Northern Ireland arrangements.[12] England’s licensing proposal and Wales’s live special-procedure list answer different legal questions.[7, 11]
Mechanism of action#
TCA causes concentration-, formulation-, contact- and tissue-dependent chemical injury followed by coagulation, desquamation and repair. The depth cannot be inferred perfectly from percentage alone.
CMed’s marketing describes a hydrophilic phase containing TCA and other ingredients and a lipophilic phase with film-forming and moisturising action.[2] Its corporate material describes the patent as a preparation and preservation system; the protocol says shaking creates a temporary emulsion.[3, 4]
No published human-skin study shows that the oil phase limits TCA penetration, reduces epidermal injury or changes healing compared with an aqueous 35% TCA control. Therefore the plausible idea that vehicle matters must remain separate from the untested claim that this vehicle makes a 35% TCA preparation behave superficially.[no source found]No published study tests whether the lipophilic phase actually limits TCA penetration depth in human skin, which is the mechanism the whole 'medium-strength acid without medium-depth injury' proposition depends on.We looked and found no source either way
The clinical changes observed with conventional TCA cannot establish BioRePeel’s mechanism or benefit because the full formulation, pH, buffering and delivered tissue effect differ or are unknown.[5, 6]
Commonly misstated claims#
“BioRePeel is clinically proven”
No clinical study of the product was located. Its only peer-reviewed mention is an unreferenced sentence of author experience in a narrative review.[1] Supported statement: BioRePeel has manufacturer documentation and generic TCA context, but no product-specific clinical trial was found.
“The biphasic system controls how deeply the acid penetrates”
The cited patent concerns preparation and preservation of hydrophilic and lipophilic phases, and no penetration study was located.[3, 4] Supported statement: The formulation is biphasic, but an effect on human-skin penetration has not been demonstrated.
“Thirty-five per cent TCA means BioRePeel is a proven medium-depth peel”
UK sources define depth by tissue destruction, while 35–50% TCA is described as a usual medium-depth concentration range.[7, 8] Supported statement: The concentration raises a medium-depth concern, but product-specific penetration depth remains unknown.
“It has no downtime”
The manufacturer page makes no no-downtime claim; a distributor says “little to no recovery time”, while a clinic handout anticipates healing and post-treatment restrictions.[14] Supported statement: Product-specific downtime has not been quantified and should not be promised as zero.[2, 13]The 'no downtime' positioning is a distributor and clinic-level claim, not a manufacturer clinical claim: CMed's own product page makes no downtime or no-peeling statement, while a UK distributor advertises 'little to no recovery time, allowing you to return to daily activities immediately' without citing any evidence.Directly tested by the source[2] CMed Aesthetics. BioRePeelCl3 FND [manufacturer product page]. Accessed 1 August 2026.Tier 4[13] Aesthderm (UK distributor). BioRePeelCl3 FND (5x6ml) [product listing]. Accessed 1 August 2026.Tier 4
“Medical-device status proves that it works”
Medical-device conformity and registration govern market access and performance against an intended purpose, not comparative benefit. Supported statement: Device status does not replace product-specific clinical evidence.[2, 3, 12]iMedical device status is a market-access route, not an efficacy endorsement: a device classification places the product outside the GB Cosmetic Products Regulation rather than subjecting it to any comparative clinical-benefit test. Under the EU MDR, conformity assessment evaluates safety and performance against the manufacturer's own stated intended purpose (Regulation (EU) 2017/745, Article 61 and Annex XIV) — not against a comparator.Inferred from adjacent evidence[2] CMed Aesthetics. BioRePeelCl3 FND [manufacturer product page]. Accessed 1 August 2026.Tier 4[3] CMed Aesthetics. About Us [manufacturer corporate page]. Accessed 1 August 2026.Tier 4[12] Medicines and Healthcare products Regulatory Agency. Regulating medical devices in the UK. GOV.UK guidance. Accessed 1 August 2026.Tier 1
No Advertising Standards Authority ruling mentioning BioRePeel exists — a search of the ASA rulings database returned no results, so UK advertising claims for the product have not been formally adjudicated.[no source found]No Advertising Standards Authority ruling mentioning BioRePeel exists — a search of the ASA rulings database returned no results, so UK advertising claims for the product have not been formally adjudicated.We looked and found no source either way
Areas of remaining uncertainty#
- Penetration depth in human skin has not been published; do not categorise BioRePeel as superficial, medium-depth or “non-invasive” without a defensible product-specific basis.
- The effect of the lipophilic phase on TCA delivery, frosting, desquamation and healing is untested; describe the biphasic mechanism as manufacturer rationale rather than demonstrated control of injury.
- The full named composition, pH, buffering capacity and concentration of ingredients other than TCA are unpublished; do not compare it quantitatively with another peel from the 35% headline alone.[2]
- Product-specific adverse-event incidence and Fitzpatrick-stratified outcomes are unknown; consent must state that risk estimates come from generic acid knowledge rather than a BioRePeel trial.
- MHRA registration, device class, conformity certificate, notified-body details and UK Responsible Person were not verified from the public pages examined; obtain them directly from the supplier rather than claiming either compliance or non-compliance.[12]
Frequently asked questions#
Is BioRePeel a cosmetic?
The manufacturer calls BioRePeelCl3 FND a topical medical device. Great Britain market access and registration therefore need to be checked on that basis.[2, 12]CMed describes BioRePeelCl3 FND as 'a two-phase topical medical device' and its corporate imprint cites Regulation (EU) 2017/745; no CE certificate number, UKCA mark, device class or notified body is published on any manufacturer or UK distributor page examined. If it is placed on the GB market as a device, MHRA guidance means it needs UKCA marking or a CE mark — MDR-compliant devices are accepted in Great Britain until 30 June 2030, MDD-certified ones only until the sooner of certificate expiry or 30 June 2028 — and it must be registered with the MHRA before being placed on the GB market, with a UK Responsible Person appointed because CMed is Italian.Directly tested by the source[2] CMed Aesthetics. BioRePeelCl3 FND [manufacturer product page]. Accessed 1 August 2026.Tier 4[12] Medicines and Healthcare products Regulatory Agency. Regulating medical devices in the UK. GOV.UK guidance. Accessed 1 August 2026.Tier 1
Is it a superficial peel?
That has not been demonstrated. UK sources define peel depth by tissue effect, and no BioRePeel histology or penetration study was located.[7, 8]UK official and consensus sources define peel depth by tissue effect, not by concentration: the JCCP defines medium depth as 'full thickness destruction of entire epidermis into upper dermis', and DHSC's 2023 consultation placed 'medium depth peels that involve full thickness destruction of entire epidermis into upper dermis' in its amber tier on the same depth-based test. DHSC's Annex A then observes that such peels 'are usually carried out using trichloroacetic acid (TCA) at concentrations between 35% and 50%' — a description of typical practice rather than a definition, but one that puts BioRePeel's headline concentration at the bottom of the range government associates with medium-depth peeling.Directly tested by the source[7] Department of Health and Social Care. Licensing of non-surgical cosmetic procedures: consultation and outcome. GOV.UK. Consultation opened 2 September 2023; outcome published 7 August 2025.Tier 1[8] Joint Council for Cosmetic Practitioners. Work Standards for Chemical Peels and Skin Rejuvenation (CPSR) — Premises Standards 005: Clinical Peels & Skin Rejuvenation. March 2018. (The document does not bear the number 'JCCPWS 005'; it cross-refers to JCCPWS 001 Minimum Requirements as a prerequisite.)Tier 4
Are there clinical studies?
No product-specific clinical trial or comparative study was located. The one peer-reviewed mention is an unsupported author anecdote.[1]
Does 35% TCA evidence prove BioRePeel works?
No. Independent studies used conventional TCA formulations in different populations and indications; they provide acid context, not BioRePeel efficacy or safety.[5, 6]Neither of the independent 35% TCA studies used BioRePeel, so their efficacy results cannot be claimed for the product and their tolerability results cannot be assumed to apply to it either — the read-across cuts both ways.Directly tested by the source[5] Kubiak M, Mucha P, Rotsztejn H. Comparative study of 15% trichloroacetic acid peel combined with 70% glycolic acid and 35% trichloroacetic acid peel for the treatment of photodamaged facial skin in aging women. Journal of Cosmetic Dermatology. 2020;19(1):137-146.Tier 3[6] Kuta V, Taylor SM. Trichloroacetic Acid as a Topical Treatment for Actinic Cheilitis. OTO Open. 2025;9(2):e70132.Tier 3
Does it have no downtime?
References#
Each source is graded by evidence tier. Tier 4 material (manufacturer documents, expert consensus, practitioner experience) is useful for protocol and context, and is never presented as equivalent to independent clinical evidence.
- Chilicka K, Rusztowicz M, Szyguła R, Nowicka D. Methods for the Improvement of Acne Scars Used in Dermatology and Cosmetology: A Review. Journal of Clinical Medicine. 2022;11(10):2744.Tier 4Supports: This is the ONLY peer-reviewed mention of BioRePeel located anywhere in the indexed literature (found via Europe PMC full-text search; the term does not appear in the PubMed-indexed abstract or title). The entire mention is one sentence, appearing inside the microneedling section: "Our experience shows that combining an MN treatment with, e.g., BioRePeel, gives much better results than performing separate treatments." It carries no citation, no patient numbers, no outcome measure, no comparator and no adverse-event data. It is author anecdote inside a narrative review, not a study finding. The paper itself is a non-systematic narrative review of acne-scar modalities; it has no methods section describing a search strategy, no inclusion criteria and no risk-of-bias assessment. Scope limit: this source supports ONLY the claim that a single unreferenced clinical opinion about BioRePeel exists in the literature. It cannot support any efficacy or safety claim.Funding / interest: Stated conflict of interest: "The authors declare no conflict of interest." Authors are at the University of Opole (Department of Health Sciences) and Wrocław Medical University, Poland. No commercial relationship with CMed Aesthetics is declared — but equally, no funding source is identified for the BioRePeel statement, which is unreferenced.
- CMed Aesthetics. BioRePeelCl3 FND [manufacturer product page]. Accessed 1 August 2026.Tier 4Supports: Verbatim composition claim: "BioRePeelCl3® FND contains 35% Trichloroacetic Acid enhanced by an innovative and functional mixture of α-hydroxyacids, β-hydroxyacids, poly-hydroxyacids, aminoacids, vitamins and GABA." Verbatim classification claim: "BioRePeelCl3® FND is a two-phase topical medical device with specific action for face, neck and décolleté." Presentation: "One box contains 5 ampoules x 6 mL each." Indication as stated: "It is indicated for use on healthy skin, as an adjuvant treatment in the prevention of acne and its scarring results." Mechanism claim: "The action of amino acids, vitamins and GABA is also assisted by the lipophilic phase thanks to its filming and moisturizing action." SCOPE LIMITS, and these matter: the page gives NO concentration for any ingredient other than TCA — the AHAs, BHAs, PHAs, amino acids, vitamins and GABA are all unquantified; it names no specific acid or amino acid; it cites no study, gives no notified body number, no CE mark number and no device class; it makes NO claim of 'no peeling' and NO claim of 'no downtime'. The page is gated behind a self-declaration prompt: "Are you a Healthcare Professional?"Funding / interest: Manufacturer's own marketing page. CMed Aesthetics S.p.A. owns the product and the BioRePeelCl₃ trademark. Total commercial interest.
- CMed Aesthetics. About Us [manufacturer corporate page]. Accessed 1 August 2026.Tier 4Supports: States the scope of the 'biphasic' patent verbatim: "Patent for bi-phasic preservation technology — Preparing and preservation system for topical products with hydrophilic and lipophilic phases." This is described as a preparation and preservation system, i.e. a formulation/stability patent — the page does not claim the patent covers a demonstrated effect on acid penetration depth in skin. A second patent is described for "sterile products preparation... Multilayer membrane system that combines ultrafiltration and microporous layers." Certifications listed: ISO 13485 ("international quality management standards for medical devices"), ISO 22716 ("good manufacturing practices for cosmetics and personal care products"), WHA-HALAL. These are quality-management certifications, not clinical evidence. Legal entity, from the same site's Imprint (accessed 1 August 2026): "CMed Aesthetics S.p.A., Via Panfilo Castaldi 4, 56121, Pisa, Italy", VAT ID IT 02266980503, legal representative Andrea Malventi, supervisory authority "Ministero della Salute", applicable rules "Regolamento UE 2017/745, Regolamento CE 1223/2009". NOTE an internal inconsistency worth flagging: the same page claims "a global footprint spanning over 80 countries" in prose while its own statistics panel states "20+ reached countries".Funding / interest: Manufacturer's own corporate page. Total commercial interest.
- CMed Aesthetics. BioRePeelCl3 protocol of use [product documentation PDF, hosted by the Spanish distributor]. Accessed 1 August 2026.Tier 4Supports: Gives the actual clinical protocol verbatim: degrease with "specific detersion products (acetone, surfactants…)"; "Shake the ampoule for a few seconds until colour turn green for a temporary emulsion" — note the manufacturer's own wording is 'temporary emulsion', which is what the two-phase system produces; withdraw with a syringe without removing the butyl stopper; "Apply the product with nitrile gloves until it is completely absorbed." Contact time: "FND: FACE, NECK AND DECOLLETE' 3/5 minutes"; "BODY: HANDS, KNEES, ELBOWS, GLUTES, FEET 5/10 minutes". Volumes: face 1.5-2 mL, neck 1-1.5 mL, décolleté 2-2.5 mL. Removal: "Clean the zone with a gauze soaked with water." Course: "BioRePeelCl3 FND is applied every 7/12 days for 4 to 6 times. BioRePeelCl3 BODY is applied every 10/15 days for 4 to 6 times." Also states, verbatim including the typo: "It is possible to treat every body zone up to doctor's discreption." SCOPE LIMIT: this is a one-page protocol sheet. It contains no contraindication list, no adverse-event guidance, no complication management, no Fitzpatrick-specific guidance and no evidence citations.Funding / interest: Manufacturer-derived product documentation distributed by a commercial distributor (biorepeelcl3spain.com). Total commercial interest.
- Kubiak M, Mucha P, Rotsztejn H. Comparative study of 15% trichloroacetic acid peel combined with 70% glycolic acid and 35% trichloroacetic acid peel for the treatment of photodamaged facial skin in aging women. Journal of Cosmetic Dermatology. 2020;19(1):137-146.Tier 3Supports: This is the closest independent comparator to BioRePeel's active agent — conventional aqueous 35% TCA at the same headline concentration. Design: comparative clinical study, 40 female patients with Glogau photoaging types II-III, allocated to two groups of 20 (35% TCA monopeel vs combined 70% glycolic acid + 15% TCA). Five sessions each, 14-day intervals. Objective instrumentation: hydration, elasticity, melanin index and erythema index by MPA-5 (Courage-Khazaka); wrinkle depth and volume by PRIMOS. Assessed before treatment, before each session, and 3 months after the last. Results: "Both peel methods achieved significant improvement in all skin parameters." Significant between-group differences were found only for hydration and melanin index, both favouring the combination. Crucially for the tolerability question: "Combination peel GA/TCA did not cause dryness, edema, or intensive lysis of the epidermis, and the frequency of peel-induced erythema did not increase with the addition of glycolic acid, but with higher concentration of the TCA solution." Conclusion verbatim: "35% TCA peel is more effective in reducing wrinkles, despite a lower tolerability." The authors classify both as "medium-depth chemical peels". "Adverse events requiring intervention or discontinuing treatment were not observed in either group." SCOPE LIMITS: n=40, single centre, women only, no stated randomisation or blinding in the abstract, no Fitzpatrick range given, and this tested plain aqueous 35% TCA — NOT BioRePeel. It cannot be read across to BioRePeel's formulation, only used to characterise what the concentration alone does.Funding / interest: No funding or conflict statement retrievable from the PubMed record. Authors are at the Medical University of Lodz, Poland (Department of Cosmetology and Aesthetic Dermatology; Department of Cosmetic Raw Material Chemistry). No product manufacturer is named as sponsor in the abstract.
- Kuta V, Taylor SM. Trichloroacetic Acid as a Topical Treatment for Actinic Cheilitis. OTO Open. 2025;9(2):e70132.Tier 3Supports: Independent prospective cohort of 35% TCA in a therapeutic indication, useful for characterising the agent rather than the brand. Design: prospective cohort, patients with actinic cheilitis presenting September 2020 to December 2023, followed twice yearly for a minimum of 2 years. n=11. A topical 35% TCA peel was applied to the lower lip "following bilateral mental nerve blocks" — i.e. the investigators judged local anaesthesia necessary at this concentration in this site. Outcomes: "the majority requiring one treatment to achieve clinical remission. All patients who completed their full treatment course entered clinical remission... and there have been no cases of recurrence to date." Adverse events: "The most common reported side effects were redness and swelling." Assessed with Skindex-16 and visual analogue scales. SCOPE LIMITS: n=11, single centre, uncontrolled, no comparator, lower lip only, therapeutic (precancerous lesion) indication not cosmetic rejuvenation, and again plain 35% TCA rather than BioRePeel. Do not read the remission figures across to aesthetic use.Funding / interest: "Conflict of interest statement: No conflicts to report." Authors at Queen Elizabeth II Health Sciences Centre, Division of Otolaryngology-Head & Neck Surgery, Dalhousie University, Canada. Registered as NCT04744103.
- Department of Health and Social Care. Licensing of non-surgical cosmetic procedures: consultation and outcome. GOV.UK. Consultation opened 2 September 2023; outcome published 7 August 2025.Tier 1Supports: The 2023 consultation document proposed a three-tier model and placed peels as follows: GREEN — "chemical peels that involve destruction only into viable epidermis (the outermost layer of the skin)"; AMBER — "medium depth peels that involve full thickness destruction of entire epidermis into upper dermis"; RED — "deeper chemical peels such as phenol peels". Its glossary states that superficial peels use "lactic, glycolic and tartaric acid" while medium-depth peels typically employ "trichloroacetic acid (TCA) at concentrations between 35% and 50%" — placing BioRePeel's headline concentration squarely at the bottom of the government's own medium-depth definition. Consultation responses were invited until 11:59pm on 28 October 2023. CRITICAL SCOPE LIMIT: this is a proposal, not law. The GOV.UK outcome summary published 7 August 2025 states that the government will "prioritise the introduction of restrictions for high-risk procedures" and that "further work is needed to determine specific procedures' classification". On legal status: "The proposals will be taken forward through secondary legislation and therefore subject to the Parliamentary process before the legal restrictions or licensing regulations can be introduced." The response document records that the consultation proposed laser and chemical-peel procedures across different categories, but it does not make those proposed placements law. No licensing scheme is in force in England as at 1 August 2026.
- Joint Council for Cosmetic Practitioners. Work Standards for Chemical Peels and Skin Rejuvenation (CPSR) — Premises Standards 005: Clinical Peels & Skin Rejuvenation. March 2018. (The document does not bear the number 'JCCPWS 005'; it cross-refers to JCCPWS 001 Minimum Requirements as a prerequisite.)Tier 4Supports: Confirms the five JCCP modalities verbatim: "Botulinum Toxins (BTs), Dermal Fillers (DFs), Chemical Peels and Skin Rejuvenation (CPSR), Laser, Intense Pulsed Light and Light Emitting Diode. (LIPLED), Hair Restoration Surgery (HRS)." Gives the UK peel-depth classification verbatim, footnoted to Health Education England (2015) Part One: Qualification requirements for delivery of cosmetic procedures: "Chemical peels involve the controlled, chemical destruction of skin at varying depths for cosmetic or medical indication. Peels can be classified as: Very Superficial: destruction of surface dead skin cell layer. Superficial: destruction into viable epidermis. Medium depth: full thickness destruction of entire epidermis into upper dermis. Deep: destruction into reticular dermis – full ablative treatment, requires sedation, cardiac monitoring, performed in theatre. Deep peels are exempt from these work standards and should be performed in a CQC registered environment." The premises standards impose specific physical requirements triggered by medium-depth peels — e.g. "If medium depth peels are performed are floors of a material impervious and easy to clean?... Where medium depth peels are performed is the area free from carpet?" and equivalent requirements for ceilings, fixtures and fittings. SCOPE LIMITS: this is a 7-page premises self-certification audit tool from March 2018, not a clinical guideline; it does not name TCA or any concentration, and it sets no practitioner-qualification threshold by depth.Funding / interest: JCCP is a Professional Standards Authority-accredited voluntary register. Not a statutory regulator; its standards bind its own registrants only.
- Public Health (Wales) Act 2017 (anaw 2), Part 4, section 57 ("What is a special procedure?"); Part 4 commenced 29 November 2024 by SI 2024/1248.Tier 1Supports: Section 57 verbatim: "Each of the following is a special procedure for the purposes of this Part— (a) acupuncture; (b) body piercing; (c) electrolysis; (d) tattooing." Commencement Information records s.57 "in force at 29.11.2024 by S.I. 2024/1248, art. 2(b)". Section 58 requires that an individual performing a special procedure in the course of a business "must do so under the authority of a special procedure licence, unless the individual performing the procedure is exempt". Section 93 gives Welsh Ministers power to ADD procedures to the section 57 list by regulations where a procedure "is capable of being performed for aesthetic purposes... and that its performance for those purposes is capable of causing harm to human health", subject to consultation. Section 60 exempts members of professions regulated by bodies within s.25(3)(a)-(ga) of the NHS Reform and Health Care Professions Act 2002. SCOPE LIMIT AND THE KEY POINT: chemical peels are not among the four listed special procedures, so BioRePeel is not a licensable activity in Wales — though the section 93 power means that could change by regulations.
- Medicines and Healthcare products Regulatory Agency. Regulating medical devices in the UK. GOV.UK guidance. Accessed 1 August 2026.Tier 1Supports: Great Britain accepts both UKCA marking and, transitionally, CE marking. Verbatim on the transition: "general medical devices, including custom-made devices, compliant with the EU MDR and IVDs compliant with the EU IVDR can be placed on the Great Britain market up until 30 June 2030." On registration, verbatim: "All medical devices, including IVDs, custom-made devices and systems or procedure packs must be registered with the MHRA before being placed on the Great Britain market." On overseas manufacturers: "the MHRA will only accept registration of devices from manufacturers where the manufacturer is based in the UK. If the manufacturer is based outside the UK, they must appoint a UK responsible person", who assumes registration responsibilities. Northern Ireland differs: EU MDR has applied there since 26 May 2021 and EU IVDR since 26 May 2022, with certain devices needing MHRA registration until 27 May 2026. SCOPE LIMIT: this guidance sets out market-access and registration mechanics. It says nothing about who may clinically administer a device, and device conformity is not a statement of comparative clinical efficacy.
- Aesthderm (UK distributor). BioRePeelCl3 FND (5x6ml) [product listing]. Accessed 1 August 2026.Tier 4Supports: Shows where the downtime claim actually originates — the distributor tier, not the manufacturer's clinical documentation. Verbatim: "Minimal downtime: Non-invasive treatment requiring little to no recovery time, allowing you to return to daily activities immediately." Confirms "35% Trichloroacetic Acid (TCA)". Describes the product as "Medical Grade" and "intended for professional use only" but states NO CE mark, NO UKCA mark, NO device class and NO notified body. Access condition, verbatim: "To use BioRePeelCl3 in your salon or clinic, you must have completed BioRePeelCl3 training and hold prior Accredited Chemical Peel certification." SCOPE LIMITS: no peeling, flaking or desquamation is mentioned anywhere on the page; no evidence is cited for the downtime claim; and the training/certification condition is a supplier's commercial term of sale, not a UK legal requirement. Note the descriptor "non-invasive" applied to a 35% TCA product, which sits awkwardly against the UK regulatory definitions in sources 7, 8, 9 and 10.Funding / interest: UK commercial distributor selling the product. Total commercial interest.
- BioRePeelcl3 (Blue) and FND (Gold) Pre Peel Instructions / Post Peel Instructions [patient information sheet, distributed by Dermestetics]. Accessed 1 August 2026.Tier 4Supports: The complete aftercare content, verbatim, is short enough to quote in full and is directly relevant to the downtime question. Pre-peel, 5-7 days prior: "AVOID: Topical Retinoids, Tretinoin, Other topical acids, any exfoliants." Pre-peel, 3-5 days prior: "AVOID: Laser Hair Removal, Waxing, Chemical Hair Removal Creams, Electrolysis." Post-peel, headed "(Until the skin is fully healed and in tact)": "AVOID: Non mineral based makeup products; ALL AHA's, BHA'S and RETINOL for 7 days; Laser hair removal, waxing, sunbeds, swimming and sauna's for 7 days." The framing "until the skin is fully healed and in tact" and the seven-day restriction window are the product's own documentation conceding a recovery period. SCOPE LIMITS: this is a one-page handout, not an IFU; it lists no contraindications, no expected reactions, no adverse events and no complication guidance; and it does not state whether visible flaking occurs.Funding / interest: Clinic/distributor-issued patient handout for the product. Commercial interest. Note this is a US clinic's document, not a UK one — cited for what the aftercare regime is, not for UK regulatory content.
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Skinipedia is written by the educators at MSTA, the medic-led skincare training academy in Liverpool.