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

NCT07614698 | Recruiting

• 1 other identifier: 2181-198-03-04-25-0095
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Skin Barrier Disruption and Recovery

Outcome Measures

Primary Outcomes (3)

• 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).

Study Arms (3)

Active treatment

EXPERIMENTAL

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

Placebo treatment

PLACEBO COMPARATOR

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

Untreated Control Site

NO INTERVENTION

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.

Interventions

Acetyl Hexapeptide-37 OTHER

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

Active treatment

Placebo OTHER

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

Placebo treatment

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:

• skin disease
• skin damage on measurement sites
• 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

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

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, intra-individual forearm study in which each participant will receive both topical treatments simultaneously. One forearm will be treated with the cream containing Acetyl Hexapeptide-37, while the contralateral forearm will be treated with placebo. Skin barrier disruption will be induced at the application sites using the tape-stripping method. An additional tape-stripped untreated skin site will serve as a control for spontaneous skin barrier recovery.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)