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

NCT07548424 | Recruiting

• 1 other identifier: 2181-198-03-04-25-0094
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Change in Transepidermal Water Loss (TEWL)

  Transepidermal water loss will be measured using a Tewameter probe to assess skin barrier function.

  Baseline and Weeks 1, 2, 3, and 4

• Change in Skin Hydration

  Skin hydration of the stratum corneum will be measured using a Corneometer probe.

  Baseline and Weeks 1, 2, 3, and 4

• Change in Skin Erythema

  Skin erythema will be measured using a Mexameter® probe.

  Baseline and Weeks 1, 2, 3, and 4

Study Arms (2)

Peptide Cream (Acetyl Hexapeptide-37)

EXPERIMENTAL

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.

Other: Acetyl Hexapeptide-37 Cream

Placebo Cream

PLACEBO COMPARATOR

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.

Other: Placebo Cream

Interventions

Acetyl Hexapeptide-37 Cream OTHER

Topical emollient cream containing Acetyl Hexapeptide-37 as the active ingredient, applied once daily to one side of the face for 4 weeks.

Peptide Cream (Acetyl Hexapeptide-37)

Placebo Cream OTHER

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.

Placebo Cream

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy volunteers who gave written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Split, School of Medicine: lead

Study Sites (1)

University of Split School of Medicine

Split, 21000, Croatia

RECRUITING

Central Study Contacts

Josipa Bukić, MPharm

CONTACT

+385917933753; jbukic@mefst.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 23, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)