Evaluation of a Peptide Cream on the Forearm Skin Recovery of Healthy Volunteers

Evaluation of the Efficacy of a Topical Formulation Containing Acetyl Hexapeptide-37 on Skin Barrier Recovery of the Forearm After Controlled Damage Using the Tape-stripping Method

The goal of this clinical trial is to evaluate the efficacy of a topical peptide-based formulation containing Acetyl Hexapeptide-37 in promoting skin barrier recovery after controlled disruption in healthy adult participants.

The main questions it aims to answer are:

• Does the peptide cream speed up the recovery of the skin barrier after it has been slightly damaged with tape-stripping method?
• How does the peptide cream compare to a placebo (a cream with no active ingredient) in improving skin hydration and reducing redness?

Researchers will compare the peptide cream to a placebo to assess its effects on skin barrier recovery

Participants will:

• Undergo controlled disruption of the skin barrier on the volar forearm using the tape-stripping method.
• One forearm will receive the peptide-based cream containing Acetyl Hexapeptide-37, while the other (contralateral) forearm will receive a placebo formulation.
• Attend scheduled visits for non-invasive assessments of skin barrier function, including transepidermal water loss, skin hydration, and erythema

Study Overview

• Status: Recruiting
• Conditions: Skin Barrier Disruption and Recovery
• Intervention / Treatment: Other: Acetyl Hexapeptide-37; Other: Placebo

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

Contacts and Locations

• Study Contact: Name: Josipa Bukić; 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:

• skin disease
• skin damage on measurement sites
• use of corticosteroids, antihistamines and immunomodulators a month prior the inclusion and during the trial
• use of emollients three days prior the inclusion in the trial
• non-adherence to the trial protocol
• exposure to artificial and excessive natural ultraviolet (UV) radiation
• pregnancy or breastfeeding
• immunosuppression
• allergic or irritant reactions to the constituents of the cream

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active treatment; One forearm will be treated with the peptide-based cream containing Acetyl Hexapeptide-37. The treated forearm (left or right) will be assigned according to the randomization protocol.	Other: Acetyl Hexapeptide-37; The emollient cream contains Acetyl Hexapeptide-37 as the active ingredient and is applied topically to designated skin areas on the forearm. Skin barrier disruption is induced prior to application using the tape-stripping method. Procedure will be performed on healthy, intact skin according to randomization protocol
Placebo Comparator: Placebo treatment; The other forearm will be treated with a placebo ointment. The allocation of the treatment (left or right forearm) will be determined according to the randomization protocol.	Other: Placebo; The emollient cream without the peptide is applied topically to designated skin areas on the forearm. Skin barrier disruption is induced prior to application using the tape-stripping method. Procedure will be performed on healthy, intact skin according to randomization protocol
No Intervention: Untreated Control Site; A designated skin site on either forearm will undergo tape-stripping to induce skin barrier disruption but will not receive any topical treatment. This site will serve as a control for natural skin barrier recovery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Transepidermal Water Loss (TEWL)	Skin barrier function will be assessed by measuring transepidermal water loss using a Tewameter TM 300 probe. Values will be expressed in g/m²/h	Assessments will be performed on 1st, 2nd, 3rd, 4th, 8th and 9th day of the trial (baseline measurements and change from baseline assessment).
Change in Skin Hydration	Hydration of the stratum corneum will be assessed using a Corneometer CM 825 probe.	Assessments will be performed on 1st, 2nd, 3rd, 4th, 8th and 9th day of the trial (baseline measurements and change from baseline assessment).
Change in Skin Erythema	Skin erythema will be assessed using a Mexameter MX 18 probe.	Assessments will be performed on 1st, 2nd, 3rd, 4th, 8th and 9th day of the trial (baseline measurements and change from baseline assessment).

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: May 20, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2181-198-03-04-25-0095

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