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

IF 1.6 4区医学 Q3 OPHTHALMOLOGY Cutaneous and Ocular Toxicology Pub Date : 2023-12-01 Epub Date: 2023-07-14 DOI:10.1080/15569527.2023.2234020

Pedro A Martínez-Carpio

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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.

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sh-oligopeptide-1的局部应用和化妆品制剂的临床试验：风险还是欺诈？

背景：sh-oligopeptide-1是一种被认为与表皮生长因子（EGF）具有生物等效性的化妆品。方法：在Medline和Google Scholar上进行专业搜索（2023年3月）。共获得22篇参考文献，选择12篇文章进行分析，其中7篇被纳入Medline。9篇文章对应于使用sh-oligopeptide-1作为功能性重组人EGF（hr-EGF）的等效物的临床试验。对制造商进行调查，并要求他们提供科学信息。结果：为了治疗糖尿病和癌症患者，使用非活性成分的临床试验结果良好。这些试验不符合医学标准。活性EGF不是一种化妆品，而是一种强效的未经授权的药物。同样，sh-oligopeptide-1不是一种功能性EGF，也未被授权用于医疗。除临床试验外，局部hr-EGF未被授权作为任何浓度的药物。然而，sh-EGF（sh-oligopeptide-1）被授权作为几种不同浓度的化妆品广泛使用，其长期风险未知。结论：由于该分子的临床前生物活性尚未得到证实，因此对其进行临床研究没有科学依据。

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来源期刊

Cutaneous and Ocular Toxicology 医学-毒理学

CiteScore

3.30

自引率

6.20%

发文量

审稿时长

1 months

期刊介绍： Cutaneous and Ocular Toxicology is an international, peer-reviewed journal that covers all types of harm to cutaneous and ocular systems. Areas of particular interest include pharmaceutical and medical products; consumer, personal care, and household products; and issues in environmental and occupational exposures. In addition to original research papers, reviews and short communications are invited, as well as concise, relevant, and critical reviews of topics of contemporary significance.