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Recruiting NCT07614698

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

No phase Interventional Skin Barrier Disruption and Recovery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acetyl Hexapeptide-37, Placebo.
Who it may be relevant to
Registry conditions: Skin Barrier Disruption and Recovery. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Croatia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • 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
  • 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

Primary outcome measures

  • Change in Transepidermal Water Loss (TEWL) [Time frame: 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 [Time frame: 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 [Time frame: Assessments will be performed on 1st, 2nd, 3rd, 4th, 8th and 9th day of the trial (baseline measurements and change from baseline assessment).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Croatia · 1 center
  • University of Split School of Medicine — Split

Identifiers

NCT: NCT07614698 · 2181-198-03-04-25-0095

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗