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

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

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

Study Overview

• Status: Recruiting
• Conditions: Skin Hydration; Skin Barrier Function; Topical Peptide Effects on Facial Skin Barrier Function
• Intervention / Treatment: Other: Acetyl Hexapeptide-37 Cream; Other: Placebo Cream

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Josipa Bukić, MPharm; Phone Number: +385917933753; Email: jbukic@mefst.hr

Study Locations

• Croatia
  • Split, Croatia, 21000
    • Recruiting
    • University of Split School of Medicine
    • Contact: Josipa Bukić; Phone Number: +385917933753; Email: jbukic@mefst.hr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peptide Cream (Acetyl Hexapeptide-37); 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; Topical emollient cream containing Acetyl Hexapeptide-37 as the active ingredient, applied once daily to one side of the face for 4 weeks.
Placebo Comparator: Placebo Cream; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Split, School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2181-198-03-04-25-0094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No