Study of a Peptide Cream's Effect on the Facial Skin Barrier Using a Side-by-Side Comparison
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acetyl Hexapeptide-37 Cream, Placebo Cream.
- Who it may be relevant to
- Registry conditions: Skin Barrier Function, Skin Hydration, Topical Peptide Effects on Facial Skin Barrier Function. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Croatia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Effect of a Topical Formulation Containing Acetyl Hexapeptide-37 on Objective Skin Barrier Parameters of the Face in a Randomized Controlled Split-Face Design
Overview
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
- Other Acetyl 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. - Other Placebo 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.
Primary outcome measures
- Change in Transepidermal Water Loss (TEWL) [Time frame: Baseline and Weeks 1, 2, 3, and 4]
- Change in Skin Hydration [Time frame: Baseline and Weeks 1, 2, 3, and 4]
- Change in Skin Erythema [Time frame: Baseline and Weeks 1, 2, 3, and 4]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Croatia · 1 center
- University of Split School of Medicine — Split
Identifiers
NCT: NCT07548424 · 2181-198-03-04-25-0094