Topical application of sh-oligopeptide-1 and clinical trials with cosmetic preparations: risk or fraud?

Cutan Ocul Toxicol. 2023 Dec;42(4):190-197. doi: 10.1080/15569527.2023.2234020. Epub 2023 Jul 14.

Abstract

Background: sh-oligopeptide-1 is a cosmetic that is considered to be the bioequivalent of the Epidermal Growth Factor (EGF).

Objective: The systematic search and selection of the information available on sh-oligopeptide-1, and field research on laboratories manufacturing cosmetics and the legal regulation of their products.

Methods: Specialised search in Medline and Google Scholar (March 2023). A total of 22 references were obtained and 12 articles were selected for analysis, 7 of which were included in Medline. 9 articles correspond to clinical trials that use sh-oligopeptide-1 as equivalent to a functional recombinant human EGF (hr-EGF). The manufacturers are investigated and they are requested to provide scientific information.

Results: Using an inactive ingredient, clinical trials are published with favourable results in order to treat diabetics and cancer patients. These trials do not follow medical standards. Active EGF is not a cosmetic, rather it is a potent unauthorised drug. Likewise, sh-oligopeptide-1 is not a functional EGF, and it is not authorised for medical treatments. Topical hr-EGF is not authorised as a medication in any concentration, except for clinical trials. However, sh-EGF (sh-oligopeptide-1) is authorised as a cosmetic in several different concentrations for generalised use, with unknown long-term risks.

Conclusion: Clinical studies on sh-oligopeptide-1 have no scientific basis, as the preclinical bioactivity of this molecule has not been proven.

Keywords: Sh-oligopeptide-1; cosmetics; epidermal growth factor; human recombinant epidermal growth factor; human synthetic epidermal growth factor.

Publication types

  • Review

MeSH terms

  • Cosmetics*
  • Epidermal Growth Factor*
  • Fraud
  • Humans
  • Oligopeptides

Substances

  • Epidermal Growth Factor
  • Cosmetics
  • Oligopeptides