Evaluation of a Peptide Cream on the Forearm Skin Recovery of Healthy Volunteers

Официальное название

Evaluation of the Efficacy of a Topical Formulation Containing Acetyl Hexapeptide-37 on Skin Barrier Recovery of the Forearm After Controlled Damage Using the Tape-stripping Method

Обзор

The goal of this clinical trial is to evaluate the efficacy of a topical peptide-based formulation containing Acetyl Hexapeptide-37 in promoting skin barrier recovery after controlled disruption in healthy adult participants. The main questions it aims to answer are: * Does the peptide cream speed up the recovery of the skin barrier after it has been slightly damaged with tape-stripping method? * How does the peptide cream compare to a placebo (a cream with no active ingredient) in improving skin hydration and reducing redness? Researchers will compare the peptide cream to a placebo to assess its effects on skin barrier recovery Participants will: * Undergo controlled disruption of the skin barrier on the volar forearm using the tape-stripping method. * One forearm will receive the peptide-based cream containing Acetyl Hexapeptide-37, while the other (contralateral) forearm will receive a placebo formulation. * Attend scheduled visits for non-invasive assessments of skin barrier function, including transepidermal water loss, skin hydration, and erythema

Вмешательства

• Другое Acetyl Hexapeptide-37
  The emollient cream contains Acetyl Hexapeptide-37 as the active ingredient and is applied topically to designated skin areas on the forearm. Skin barrier disruption is induced prior to application using the tape-stripping method. Procedure will be performed on healthy, intact skin according to randomization protocol
• Другое Placebo
  The emollient cream without the peptide is applied topically to designated skin areas on the forearm. Skin barrier disruption is induced prior to application using the tape-stripping method. Procedure will be performed on healthy, intact skin according to randomization protocol

Первичные конечные точки

• Change in Transepidermal Water Loss (TEWL) [Срок оценки: Assessments will be performed on 1st, 2nd, 3rd, 4th, 8th and 9th day of the trial (baseline measurements and change from baseline assessment).]
• Change in Skin Hydration [Срок оценки: Assessments will be performed on 1st, 2nd, 3rd, 4th, 8th and 9th day of the trial (baseline measurements and change from baseline assessment).]
• Change in Skin Erythema [Срок оценки: Assessments will be performed on 1st, 2nd, 3rd, 4th, 8th and 9th day of the trial (baseline measurements and change from baseline assessment).]

Критерии участия

Критерии включения

• healthy volunteers who gave written informed consent

Критерии исключения

• skin disease
• skin damage on measurement sites
• use of corticosteroids, antihistamines and immunomodulators a month prior the inclusion and during the trial
• use of emollients three days prior the inclusion in the trial
• non-adherence to the trial protocol
• exposure to artificial and excessive natural ultraviolet (UV) radiation
• pregnancy or breastfeeding
• immunosuppression
• allergic or irritant reactions to the constituents of the cream

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Хорватия · 1 центр

• University of Split School of Medicine — Split

Идентификаторы

NCT: NCT07614698 · 2181-198-03-04-25-0095

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗