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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:
Researchers will compare the peptide cream to a placebo to assess its effects on skin barrier recovery
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josipa Bukić | Contact | +385917933753 | jbukic@mefst.hr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Split School of Medicine | Recruiting | Split | 21000 | Croatia |
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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.
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| 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 |
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