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

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 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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

healthy volunteers who gave written informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acetyl Hexapeptide-37

    Other intervention

    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

    Other intervention

    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

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Active treatmentExperimental treatment 1 intervention
Group B: Placebo treatmentPlacebo comparator 1 intervention
Group C: Untreated Control SiteNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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).
2

Change in Skin Hydration

Hydration of the stratum corneum will be assessed using a Corneometer CM 825 probe.

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).
3

Change in Skin Erythema

Skin erythema will be assessed using a Mexameter MX 18 probe.

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).

Secondary outcomes

Other outcomes

Sponsors and contacts

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