Evaluation of a Peptide Cream on the Forearm Skin Recovery of Healthy Volunteers
15 juni 2026 uppdaterad av: University of Split, School of Medicine
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
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
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
30
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Josipa Bukić
- Telefonnummer: +385917933753
- E-post: jbukic@mefst.hr
Studieorter
-
-
-
Split, Kroatien, 21000
- Rekrytering
- University of Split School of Medicine
-
Kontakt:
- Josipa Bukić
- Telefonnummer: +385917933753
- E-post: jbukic@mefst.hr
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Active treatment
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.
|
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-jämförare: Placebo treatment
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.
|
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
|
|
Inget ingripande: Untreated Control Site
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Transepidermal Water Loss (TEWL)
Tidsram: 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
|
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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Change in Skin Hydration
Tidsram: 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.
|
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
Tidsram: 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.
|
Assessments will be performed on 1st, 2nd, 3rd, 4th, 8th and 9th day of the trial (baseline measurements and change from baseline assessment).
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juni 2026
Primärt slutförande (Beräknad)
1 januari 2027
Avslutad studie (Beräknad)
1 januari 2027
Studieregistreringsdatum
Först inskickad
20 maj 2026
Först inskickad som uppfyllde QC-kriterierna
20 maj 2026
Första postat (Faktisk)
29 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2181-198-03-04-25-0095
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .