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RecruitingNCT07614698Updated Jun 17, 2026

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

An interventional study of Acetyl Hexapeptide-37 and Placebo in Skin Barrier Disruption and Recovery, sponsored by University of Split, School of Medicine. Recruiting at 1 site in Croatia. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-17.

Sponsored by University of Split, School of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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
02

Conditions studied

  • Skin Barrier Disruption and Recovery
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy volunteers who gave written informed consent

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    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.

    Other: Acetyl Hexapeptide-37

  • Placebo comparator
    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.

    Other: Placebo

  • No intervention
    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.

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

05

What researchers measure

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).

06

Study locations

1 of 1 sites recruiting
  • University of Split School of Medicine
    Split, 21000, Croatia
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07614698
Lead sponsor
University of Split, School of Medicine
Responsible party
Sponsor
First posted
May 29, 2026
Start date
Jun 1, 2026
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Jun 17, 2026

Study contacts

Josipa Bukić
Contact
jbukic@mefst.hr
+385917933753

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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