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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Split, School of Medicine

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

healthy volunteers who gave written informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acetyl Hexapeptide-37 Cream

    Other intervention

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

  • Placebo Cream

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Peptide Cream (Acetyl Hexapeptide-37)Experimental treatment 1 intervention
Group B: Placebo CreamPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Transepidermal Water Loss (TEWL)

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

Time frame
Baseline and Weeks 1, 2, 3, and 4
2

Change in Skin Hydration

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

Time frame
Baseline and Weeks 1, 2, 3, and 4
3

Change in Skin Erythema

Skin erythema will be measured using a Mexameter® probe.

Time frame
Baseline and Weeks 1, 2, 3, and 4

Secondary outcomes

Other outcomes

Sponsors and contacts

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