Skin Barrier Function, Skin Hydration, Topical Peptide Effects on Facial Skin Barrier Function
Conditions
Brief summary
The goal of this clinical trial is to evaluate whether a topical face cream containing the peptide Acetyl Hexapeptide-37 improves skin hydration and strengthens the skin barrier compared to a placebo cream in healthy adult participants. The study uses a split-face design, in which one side of the face is treated with the peptide cream and the other side with a placebo (a cream without the active ingredient). The main questions it aims to answer are: * Does the peptide cream improve skin hydration and reduce transepidermal water loss compared to placebo? * Does the peptide cream affect skin erythema or cause irritation? * How do participants rate the comfort and tolerability of the peptide cream? Researchers will compare the treated and placebo sides of the face to assess differences in skin barrier function and tolerability. Participants will: * Attend a baseline visit for assessment of facial skin parameters, including hydration, transepidermal water loss, and erythema * Apply the peptide cream to one side of the face and the placebo cream to the other side once daily for 4 weeks * Attend weekly follow-up visits for non-invasive skin measurements * Record any skin sensations (e.g., stinging, tightness) or adverse effects throughout the study
Interventions
OTHERAcetyl Hexapeptide-37 Cream
Topical emollient cream containing Acetyl Hexapeptide-37 as the active ingredient, applied once daily to one side of the face for 4 weeks.
OTHERPlacebo Cream
Topical emollient cream identical in composition to the investigational product but without Acetyl Hexapeptide-37, applied once daily to the contralateral side of the face for 4 weeks.
Sponsors
University of Split, School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
This is a randomized, placebo-controlled, split-face study in which one side of the face will receive the peptide cream and the other side will receive placebo, with side allocation determined by randomization.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy volunteers who gave written informed consent
Exclusion criteria
* presence of active skin diseases or dermatological conditions * known allergy or hypersensitivity to any ingredient of the study products * pregnancy or breastfeeding * use of topical or systemic corticosteroids, immunosuppressive drugs, or antihistamines prior to or during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Transepidermal Water Loss (TEWL) | Baseline and Weeks 1, 2, 3, and 4 | Transepidermal water loss will be measured using a Tewameter probe to assess skin barrier function. |
| Change in Skin Hydration | Baseline and Weeks 1, 2, 3, and 4 | Skin hydration of the stratum corneum will be measured using a Corneometer probe. |
| Change in Skin Erythema | Baseline and Weeks 1, 2, 3, and 4 | Skin erythema will be measured using a Mexameter® probe. |
Countries
Croatia
Outcome results
None listed