Skin Barrier Disruption and RecoveryNCT07614698
Evaluation of a Peptide Cream on the Forearm Skin Recovery of Healthy Volunteers
A study testing Acetyl Hexapeptide-37 in people with Skin Barrier Disruption and Recovery, run by University of Split, School of Medicine at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Barrier Disruption and Recovery
- What is being tested?
- Acetyl Hexapeptide-37
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jun 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers who gave written informed consent
Who cannot join
- 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
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- pregnancy or breastfeeding
- immunosuppression
- allergic or irritant reactions to the constituents of the cream
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
University of Split School of Medicine
Split, 21000
Josipa Bukić, +385917933753, jbukic@mefst.hr
About this study
Official title: 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:
Read more
- 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
- Conditions
- Skin Barrier Disruption and Recovery
- Being tested
- Acetyl Hexapeptide-37, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetyl Hexapeptide-37Other
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
PlaceboOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Acetyl Hexapeptide-37 |
| 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. Receives: Other: Placebo |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Assessments will be performed on 1st, 2nd, 3rd, 4th, 8th and 9th day of the trial (baseline measurements and change from baseline assessment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jun 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Barrier Disruption and RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614698
- Sponsor's protocol ID
- 2181-198-03-04-25-0095
- Status last verified
- Jun 2026
- First submitted
- 20 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07614698
- Acronym / sponsor ID
- 2181-198-03-04-25-0095
- Conditions
- Skin Barrier Disruption and Recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Other: Acetyl Hexapeptide-37One 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. |
| Placebo treatment | Placebo comparator | Other: PlaceboThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers who gave written informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetyl Hexapeptide-37The 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 | Other | Active treatment |
| PlaceboThe 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 | Other | Placebo treatment |
Primary outcome
Change in Transepidermal Water Loss (TEWL)
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).
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
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).
Hydration of the stratum corneum will be assessed using a Corneometer CM 825 probe.
Change in Skin Erythema
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).
Skin erythema will be assessed using a Mexameter MX 18 probe.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetyl Hexapeptide-37 in people with Skin Barrier Disruption and Recovery, run by University of Split, School of Medicine at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josipa Bukić (+385917933753, jbukic@mefst.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Transepidermal Water Loss (TEWL) (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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.