Cosmetic EGF and bFGF

Sh-oligopeptide-1: recombinant human epidermal growth factor, rhEGF, "EGF" in skincare. Sh-polypeptide-1: recombinant human basic fibroblast growth factor, bFGF, FGF-2, "FGF" in skincare. "sh" = synthetic human (recombinant)

Skin & cosmetic

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Note on this profile. These are not small peptides. EGF is a 53-amino-acid protein and bFGF a protein of roughly 146 amino acids; both are hormone-like signalling proteins made by recombinant DNA technology. Pharmaceutical versions are approved medicines for wound healing in some countries. In cosmetics they are used at tiny concentrations with "appearance" claims only. The gap between the drug science and the cosmetic claims is the subject of a long-running controversy, described below.

Summary

Class: Recombinant human growth-factor proteins (EGF ~6.2 kDa; bFGF ~17 kDa), produced in bacteria, yeast, plants or human cell lines
Mechanism: EGF drives keratinocyte and fibroblast proliferation and migration via the EGF receptor; bFGF drives fibroblast proliferation, collagen synthesis and new blood-vessel growth via FGF receptors
Routes studied: Topical on open wounds and burns (medicines); intralesional injection (EGF for diabetic foot ulcers); topical on intact skin (cosmetics); micro-needling adjunct (community/clinic)
Dose range reported: Medicines: EGF topical gels/sprays ~0.005–0.01% (Korea, India, China) and 75 µg intralesional three times weekly (Cuba, diabetic foot) †; bFGF spray 0.01% (trafermin, Japan). Cosmetics: EGF typically 0.0001–0.001% (1–10 ppm); Korea caps EGF in cosmetics at 0.001% †; bFGF similar trace levels
Half-life: Minutes in plasma; rapidly degraded by proteases on skin and in wound fluid
Storage: Proteins are fragile: refrigerate concentrates; finished cosmetics rely on stabilisers and should be kept cool and away from light; many lose activity over weeks once opened
Regulatory status: Approved medicines for wounds in some countries (not US/EU for EGF; bFGF approved in Japan); permitted cosmetic ingredients in most markets with claim and concentration restrictions in some

Doses are as reported in studies or by the community — never recommendations.

1What it is

Epidermal growth factor was discovered by Stanley Cohen in the 1960s (Nobel Prize 1986). It is one of the body's main "grow and close the wound" signals for skin cells. Basic fibroblast growth factor was identified in the 1970s–80s and does a similar job for the deeper, connective-tissue layer and for blood vessels. Both are naturally occurring human proteins.

Recombinant versions have been medicines for decades in some countries: EGF gels and sprays for burns and diabetic ulcers in South Korea, China and India; injectable EGF for advanced diabetic foot ulcers in Cuba and other countries; bFGF spray (trafermin) for pressure ulcers and burns in Japan since 2001. Neither has US or EU approval as a drug.

In the 2000s, first Korean and then global cosmetics began adding trace amounts of these proteins to serums, with the INCI names sh-oligopeptide-1 and sh-polypeptide-1, marketing them as "regenerating" and "anti-ageing". A separate category — conditioned media from cultured fibroblasts or stem cells, which contain mixtures of growth factors — followed the same logic. This is where the controversy lives.

2How it's thought to work

EGF. binds the EGF receptor (EGFR) on keratinocytes and fibroblasts → proliferation, migration, faster epidermal closure. In a wound this is clearly useful.

bFGF. binds FGFR1/2 on fibroblasts and endothelial cells → fibroblast proliferation, collagen and matrix synthesis, , and granulation-tissue formation.

On intact skin — the problem. the outer skin barrier excludes molecules much above ~500 Da. EGF is ~6,200 Da and bFGF ~17,000 Da. On intact skin, meaningful penetration to the living epidermis and dermis is implausible without disruption (micro-needling, laser, ablation). Proponents argue that even surface action on keratinocytes or signalling through hair-follicle openings is enough; critics argue that any visible effect is from the vehicle. Any "deep" effect claimed for a serum on intact skin needs a delivery explanation.

Proposed: a mixed category sold on one promise — growth factors applied to skin to make fibroblasts lay down collagen. The standing objection is drawn here: these are large molecules, and the outer skin barrier is what they would have to cross to reach the cells that could respond.Schematic — not to scale

3What the research shows

Wound healing, EGF (medicine)

Randomised, controlled trials of topical EGF accelerated healing of skin-graft donor sites (Brown 1989, NEJM) and of diabetic foot ulcers; intralesional EGF (Heberprot-P) increased complete healing of advanced diabetic foot ulcers in randomised trials (Fernández-Montequín 2009, Int Wound J; Berlanga-Acosta 2009 review, Int Wound J). Also positive trials for burns and chronic ulcers in Korea and China †. [1][2][3]

Wound healing, bFGF (medicine)

Trafermin spray improved healing of pressure ulcers, burns and skin-graft donor sites in Japanese randomised trials, and later reports suggest improved scar quality when used on fresh wounds (Akita 2008, Wound Repair Regen; Ono and others †). Approved in Japan since 2001. [4]

Photoageing, EGF serum (cosmetic)

A 12-week open-label study of a serum containing barley-produced recombinant EGF in 29 women reported improvements in fine lines, texture and pore appearance by investigator and self-assessment (Schouest, Luu & Moy 2012, J Drugs Dermatol). Small, uncontrolled, manufacturer-supported. [5]

Photoageing, growth-factor mixtures (cosmetic)

Fibroblast conditioned-medium products (which contain EGF, bFGF and others) improved photodamage scores and, in one study, increased epidermal thickness and dermal collagen on biopsy in 14 patients after 60 days (Fitzpatrick & Rostan 2003, J Cosmet Laser Ther); later small trials of similar products reported improvements in wrinkles and texture (Mehta 2008; Gold 2007, J Drugs Dermatol). Industry-funded, mostly open-label; mixtures, so no single factor can be credited. [6]

Graded B/—

Micro-needling plus growth factors

Clinic practice combines micro-needling with EGF or bFGF solutions to get past the barrier. Small case series report improved acne scars and texture †; this moves the product into drug-like use through broken skin, which no regulator has approved for cosmetic purposes.

Graded B/—

Pigmentation and scars

Korean EGF products are heavily marketed for post-acne redness and scars; small open studies exist. The Korean regulator cracked down in 2020 on exactly these claims (see below).

4Reported side effects and interactions

Literature-reported

Literature (medicines). topical EGF and bFGF are well tolerated on wounds; injectable EGF causes injection-site pain, burning, shivering and occasional hypotension in trials. The core long-term question for both is cancer: EGFR is over-expressed in many carcinomas and anti-EGFR drugs are cancer treatments; bFGF is . Follow-up of wound-treated patients has not shown increased cancer rates to date, but the datasets are small and short by oncology standards (Berlanga-Acosta 2009). Regulators approving these drugs required that they be applied to wounds for limited periods, not daily for years.

Community-reported

Community-reported (cosmetics). generally well tolerated; some report redness or "congestion"; many report no visible effect. Reports of milia or small bumps with heavy growth-factor serums are common anecdotally.

Theoretical. (1) daily, indefinite application of mitogens to the face — including on actinic keratoses or undiagnosed early skin cancers — is a plausible concern with no reassuring long-term data either way; dermatologists commonly advise against use over suspicious lesions or in people with a skin-cancer history; (2) immune sensitisation to recombinant proteins from non-human expression systems is possible but rarely reported; (3) products often cannot demonstrate that the protein is still active in the bottle.

Interactions. none established. Combination with procedures that breach the barrier (needling, lasers, peels) increases exposure and moves the product into off-label drug territory.

Markers researchers commonly monitor

No blood markers are relevant to trace topical use. What dermatologists and careful users track:

Marker	Why it's watched
Full-skin examination / mole and lesion photographs before starting and yearly	because the compounds are mitogens, the sensible precaution is to know what is on the skin first and not apply over anything suspicious.
Standardised facial photographs every 4 weeks
For medical wound use: wound area tracing/photography weekly, infection signs, and (for injectable EGF) blood pressure during administration	hospital protocol, not self-care.
Forearm patch test before first use of any recombinant-protein product

Free for everyone. Safety information is never behind a paywall.

5Formulation and handling

These are proteins, not peptide powders. Cosmetic serums contain them at 1–10 ppm with stabilisers; some brands supply ampoules to be mixed with a and used within days. Keep cool, avoid heat and repeated air exposure; discard at the labelled period after opening. There is no reliable home test of activity. The site calculator does not apply; no injectable or home-reconstitution protocol is documented for cosmetic use, and the pharmaceutical injectable (EGF for diabetic foot) is a hospital procedure.

6Commonly studied alongside

GHK-Cu (#5), palmitoyl tripeptide-1 (#181), hyaluronic acid, niacinamide (in Korean "EGF ampoules"); fibroblast and stem-cell conditioned media; micro-needling and fractional laser (as delivery adjuncts); TB-500 / thymosin β4 (#2, another wound-healing protein studied topically).

Informational cross-links. Not stack recommendations.

7Regulatory status by region

Region	Status (checked —)
United States	No FDA-approved EGF or bFGF drug. Permitted as cosmetic ingredients when only appearance claims are made; FDA has issued warning letters to growth-factor skincare brands for drug claims ("stimulates collagen", "heals") †
European Union	Not authorised as medicines. Sh-oligopeptide-1 and sh-polypeptide-1 are CosIng-listed and used in EU cosmetics; recombinant human proteins face scrutiny under the "medicinal by function" borderline and claims rules, and some member-state authorities have challenged "EGF" marketing †
United Kingdom	Same as EU position; no licensed EGF/bFGF medicine
Australia	Permitted as cosmetic ingredients with cosmetic claims; no TGA-registered EGF or bFGF product
South Africa	Permitted in cosmetics; no SAHPRA-registered product
Korea / Japan / China / India / Cuba (for context)	EGF approved as a wound drug in Korea, China, India and Cuba; bFGF (trafermin) approved in Japan. Korea restricts EGF in cosmetics to ≤0.001% and in 2020 the MFDS acted against 549 online listings making medical claims for EGF cosmetics
Sport (WADA)	Growth factors affecting muscle, tendon or vascular protein synthesis are prohibited under S2 (e.g. FGFs are named); a trace topical cosmetic is unlikely to trigger a finding but athletes should note bFGF's S2 listing †

8Open questions

Does any EGF or bFGF in a serum penetrate intact skin at a biologically relevant dose? No convincing published penetration study exists for cosmetic products.
Long-term safety of daily mitogen exposure on sun-damaged skin — the central unresolved question, and unlikely to be answered by cosmetic-scale trials.
How much of the protein in retail products is still active at purchase and after opening? Independent assays are rare.
Whether micro-needling delivery of growth factors should be regulated as a drug/device procedure — regulators have not resolved this.

9References

1Brown GL et al. (1989). Enhancement of wound healing by topical treatment with epidermal growth factor. N Engl J Med. PubMed · DOI
2Berlanga-Acosta J et al. (2009). Epidermal growth factor in clinical practice — a review of its biological actions, clinical indications and safety implications. Int Wound J. PubMed · DOI
3Fernández-Montequín JI et al. (2009). Intra-lesional injections of recombinant human epidermal growth factor promote granulation and healing in advanced diabetic foot ulcers: multicenter, randomised, placebo-controlled, double-blind study. Int Wound J. PubMed · DOI
4Akita S et al. (2008). Basic fibroblast growth factor accelerates and improves second-degree burn wound healing. Wound Repair Regen. PubMed · DOI
5Schouest JM, Luu TK, Moy RL (2012). Improved texture and appearance of human facial skin after daily topical application of barley produced, synthetic, human-like epidermal growth factor (EGF) serum. J Drugs Dermatol. PubMed
6Fitzpatrick RE, Rostan EF (2003). Reversal of photodamage with topical growth factors: a pilot study. J Cosmet Laser Ther. PubMed · DOI
7Mehta RC, Fitzpatrick RE (2007). Endogenous growth factors as cosmeceuticals. Dermatol Ther. PubMed · DOI
8Ministry of Food and Drug Safety (Korea) (2020). Enforcement action on online advertising of EGF-containing cosmetics (reported in trade press, July 2020). PubMed

References are being resolved to PubMed/DOI identifiers; links search PubMed for the citation until then.

† Being confirmed by our reviewers against current sources.

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11Page history

31 Oct 2026Profile published — awaiting medical review

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