Study of a Peptide Cream's Effect on the Facial Skin Barrier Using a Side-by-Side Comparison

University of Split

Status: Enrolling

Conditions: Topical Peptide Effects on Facial Skin Barrier Function; Skin Hydration; Skin Barrier Function

Treatments: Other: Acetyl Hexapeptide-37 Cream; Other: Placebo Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT07548424

2181-198-03-04-25-0094

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Peptide Cream (Acetyl Hexapeptide-37)

Experimental group

Description:

Participants will apply a topical cream containing Acetyl Hexapeptide-37 to one side of the face once daily for 4 weeks. The side of application (left or right) will be determined according to the randomization protocol.

Treatment:

Other: Acetyl Hexapeptide-37 Cream

Placebo Cream

Placebo Comparator group

Description:

Participants will apply a placebo cream (an identical emollient formulation without the peptide) to the contralateral side of the face once daily for 4 weeks. The side of application (left or right) will be determined according to the randomization protocol.

Treatment:

Other: Placebo Cream