Skin Barrier Disruption and Recovery
Conditions
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
Interventions
OTHERAcetyl 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
OTHERPlacebo
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
Sponsors
University of Split, School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Transepidermal Water Loss (TEWL) | Assessments will be performed on 1st, 2nd, 3rd, 4th, 8th and 9th day of the trial (baseline measurements and change from baseline assessment). | 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 |
| Change in Skin Hydration | Assessments will be performed on 1st, 2nd, 3rd, 4th, 8th and 9th day of the trial (baseline measurements and change from baseline assessment). | Hydration of the stratum corneum will be assessed using a Corneometer CM 825 probe. |
| Change in Skin Erythema | Assessments will be performed on 1st, 2nd, 3rd, 4th, 8th and 9th day of the trial (baseline measurements and change from baseline assessment). | Skin erythema will be assessed using a Mexameter MX 18 probe. |
Countries
Croatia
Contacts
CONTACTJosipa Bukić
Outcome results
None listed