SH-OLIGOPEPTIDE-1

Atopic dermatitis (AD) is a chronic inflammatory skin condition that affects up to 25% of children and impairs both skin barrier function and quality of life. This study examined the effectiveness of an emulgel containing hyaluronic acid, glycerol, grape seed oil, Calendula officinalis , aloe vera and sh-oligopeptide-1 (a synthetic Epidermal Growth Factor) for treating paediatric AD. In a randomised, self-controlled trial, 57 children (aged 2-14) applied the emulgel twice daily for 10 days to one forearm and left the other forearm as a control. Skin barrier parameters such as transepidermal water loss (TEWL), stratum corneum hydration (SCH), erythema and pH were measured. After applying the emulgel, lesional skin showed reduced erythema ( p = 0.007), lower TEWL ( p = 0.002) and higher SCH ( p < 0.001). Non-lesional skin showed improved SCH ( p < 0.001). SCORing Atopic Dermatitis (SCORAD) and Eczema Area and Severity Index (EASI) scores indicated milder disease post-treatment (mild cases: 64.9% to 80.7% SCORAD; 82.5% to 93.0%EASI). The Dermatology Life Quality Index improved by ~3.5 points, and patients reported high satisfaction with no adverse effects. This emulgel is an effective and well-tolerated adjunctive therapy for paediatric AD, enhancing barrier function and clinical outcomes.

sh-oligopeptide-1 is a cosmetic that is considered to be the bioequivalent of the Epidermal Growth Factor (EGF). 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. 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. 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. Clinical studies on sh-oligopeptide-1 have no scientific basis, as the preclinical bioactivity of this molecule has not been proven.

Muscle pain and stiffness are strictly interconnected. Injuries frequently occur during sport activities, causing muscle pain, with or without stiffness, and require effective as well as fast-acting treatments. Topical products can be ideal for the treatment of such physical alterations as they are convenient and simple to use. In this study, it was investigated the application of a novel topical formulation, EGYFIL™, for the treatment of pain and stiffness due to muscle contracture, trauma, and/or overtraining. The lotion is composed of hyaluronic acid, a well-known ingredient for the pain alleviation, mixed with skin conditioning SH-Polypeptide-6 and SH-Oligopeptide-1, embedded in it. Twenty-six patients with pain and/or stiffness were enrolled. After a screening visit (Time 0, t0), patients were treated for the first time with the IP. The treatment consisted of topical application of the pain lotion. Level of pain and stiffness were measured with Numerical Rating Scale (NRS). Patients' pain and/or stiffness were evaluated at t0 (prior to using the product), after three hours (t1), and after three days (t2) of treatment. Participants were free to apply and re-apply the product ad libitum over the course of the study period (3 days). Potential adverse events (AE) and tolerance were evaluated during each visit. There was a 22% decrease in pain in the first three hours (p < 0.001), followed by an additional 20% decrease after three days (p=0.0873). Overall, there was a 42% decrease in pain over the three days of the study (p =0.001). Furthermore, a 24% reduction in stiffness in the first three hours (p=0.025) and a 38% decrease in stiffness over three days (p < 0.001) were observed. Reduction in pain and stiffness were neither age, nor sex dependent. No adverse effects were reported during the study. EGYFIL™ is safe and seems to reduce pain and stiffness in patients during the 3 days of treatment, already after 3 h from the first application. ClinicalTrials.gov ID: NCT05711953. This trial was registered on 03/02/2023.