Skin Barrier FunctionNCT07548424
Study of a Peptide Cream's Effect on the Facial Skin Barrier Using a Side-by-Side Comparison
A study testing Acetyl Hexapeptide-37 Cream in people with Skin Barrier Function and Skin Hydration, run by University of Split, School of Medicine at 1 site in Croatia.
Trial summary
The goal of this clinical trial is to evaluate whether a topical face cream containing the peptide Acetyl Hexapeptide-37 improves skin hydration and strengthens the skin barrier compared to a placebo cream 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 Function, Skin Hydration, Topical Peptide Effects on Facial Skin Barrier Function
- What is being tested?
- Acetyl Hexapeptide-37 Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCroatia
- Study dates
- 4 May 2026to 14 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- presence of active skin diseases or dermatological conditions
- known allergy or hypersensitivity to any ingredient of the study products
- pregnancy or breastfeeding
- use of topical or systemic corticosteroids, immunosuppressive drugs, or antihistamines prior to or during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Acetyl Hexapeptide-37 in a Topical Formulation on Forehead Skin Barrier: a Doubleblind Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether a topical face cream containing the peptide Acetyl Hexapeptide-37 improves skin hydration and strengthens the skin barrier compared to a placebo cream in healthy adult participants. The study uses a split-face design, in which one side of the face is treated with the peptide cream and the other side with a placebo (a cream without the active ingredient).
The main questions it aims to answer are:
Read more
- Does the peptide cream improve skin hydration and reduce transepidermal water loss compared to placebo?
- Does the peptide cream affect skin erythema or cause irritation?
- How do participants rate the comfort and tolerability of the peptide cream?
Researchers will compare the treated and placebo sides of the face to assess differences in skin barrier function and tolerability.
Participants will:
- Attend a baseline visit for assessment of facial skin parameters, including hydration, transepidermal water loss, and erythema
- Apply the peptide cream to one side of the face and the placebo cream to the other side once daily for 4 weeks
- Attend weekly follow-up visits for non-invasive skin measurements
- Record any skin sensations (e.g., stinging, tightness) or adverse effects throughout the study
- Conditions
- Skin Barrier Function, Skin Hydration, Topical Peptide Effects on Facial Skin Barrier Function
- Being tested
- Acetyl Hexapeptide-37 Cream, Placebo Cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetyl Hexapeptide-37 CreamOther
Topical emollient cream containing Acetyl Hexapeptide-37 as the active ingredient, applied once daily to one side of the face for 4 weeks.
Placebo CreamOther
Topical emollient cream identical in composition to the investigational product but without Acetyl Hexapeptide-37, applied once daily to the contralateral side of the face for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Peptide Cream (Acetyl Hexapeptide-37) | Experimental | Participants will apply a topical cream containing Acetyl Hexapeptide-37 to one side of the face once daily for 4 weeks. The side of application (left or right) will be determined according to the randomization protocol. Receives: Other: Acetyl Hexapeptide-37 Cream |
| Placebo Cream | Placebo comparator | Participants will apply a placebo cream (an identical emollient formulation without the peptide) to the contralateral side of the face once daily for 4 weeks. The side of application (left or right) will be determined according to the randomization protocol. Receives: Other: Placebo Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Transepidermal Water Loss (TEWL)
Transepidermal water loss will be measured using a Tewameter probe to assess skin barrier function.
Measured: Baseline and Weeks 1, 2, 3, and 4
Change in Skin Hydration
Skin hydration of the stratum corneum will be measured using a Corneometer probe.
Measured: Baseline and Weeks 1, 2, 3, and 4
Change in Skin Erythema
Skin erythema will be measured using a Mexameter® probe.
Measured: Baseline and Weeks 1, 2, 3, and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start4 May 2026
- Primary completion14 Sep 2026
- Study completion14 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Barrier FunctionStudies 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, split-face study in which one side of the face will receive the peptide cream and the other side will receive placebo, with side allocation determined by randomization.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
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
- NCT07548424
- Sponsor's protocol ID
- 2181-198-03-04-25-0094
- Status last verified
- Sep 2026
- First submitted
- 16 Apr 2026
- Last updated
- 17 Sep 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 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Acetyl Hexapeptide-37 in a Topical Formulation on Forehead Skin Barrier: a Doubleblind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07548424
- Acronym / sponsor ID
- 2181-198-03-04-25-0094
- Conditions
- Skin Barrier Function, Skin Hydration, Topical Peptide Effects on Facial Skin Barrier Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Study start
- 4 May 2026 (actual)
- Primary completion
- 14 Sep 2026 (actual)
- Study completion
- 14 Sep 2026 (actual)
- First posted
- 23 Apr 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 whether a topical face cream containing the peptide Acetyl Hexapeptide-37 improves skin hydration and strengthens the skin barrier compared to a placebo cream in healthy adult participants. The study uses a split-face design, in which one side of the face is treated with the peptide cream and the other side with a placebo (a cream without the active ingredient).
The main questions it aims to answer are:
- Does the peptide cream improve skin hydration and reduce transepidermal water loss compared to placebo?
- Does the peptide cream affect skin erythema or cause irritation?
- How do participants rate the comfort and tolerability of the peptide cream?
Researchers will compare the treated and placebo sides of the face to assess differences in skin barrier function and tolerability.
Participants will:
- Attend a baseline visit for assessment of facial skin parameters, including hydration, transepidermal water loss, and erythema
- Apply the peptide cream to one side of the face and the placebo cream to the other side once daily for 4 weeks
- Attend weekly follow-up visits for non-invasive skin measurements
- Record any skin sensations (e.g., stinging, tightness) or adverse effects throughout the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, placebo-controlled, split-face study in which one side of the face will receive the peptide cream and the other side will receive placebo, with side allocation determined by randomization.
| Arm | Type | Receives |
|---|---|---|
| Peptide Cream (Acetyl Hexapeptide-37) | Experimental | Other: Acetyl Hexapeptide-37 CreamParticipants will apply a topical cream containing Acetyl Hexapeptide-37 to one side of the face once daily for 4 weeks. The side of application (left or right) will be determined according to the randomization protocol. |
| Placebo Cream | Placebo comparator | Other: Placebo CreamParticipants will apply a placebo cream (an identical emollient formulation without the peptide) to the contralateral side of the face once daily for 4 weeks. The side of application (left or right) will be determined according to the randomization protocol. |
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 (4 listed)
- presence of active skin diseases or dermatological conditions
- known allergy or hypersensitivity to any ingredient of the study products
- pregnancy or breastfeeding
- use of topical or systemic corticosteroids, immunosuppressive drugs, or antihistamines prior to or during the study
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-37 CreamTopical emollient cream containing Acetyl Hexapeptide-37 as the active ingredient, applied once daily to one side of the face for 4 weeks. | Other | Peptide Cream (Acetyl Hexapeptide-37) |
| Placebo CreamTopical emollient cream identical in composition to the investigational product but without Acetyl Hexapeptide-37, applied once daily to the contralateral side of the face for 4 weeks. | Other | Placebo Cream |
Primary outcome
Change in Transepidermal Water Loss (TEWL)
Time frame: Baseline and Weeks 1, 2, 3, and 4
Transepidermal water loss will be measured using a Tewameter probe to assess skin barrier function.
Change in Skin Hydration
Time frame: Baseline and Weeks 1, 2, 3, and 4
Skin hydration of the stratum corneum will be measured using a Corneometer probe.
Change in Skin Erythema
Time frame: Baseline and Weeks 1, 2, 3, and 4
Skin erythema will be measured using a Mexameter® probe.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Cream in people with Skin Barrier Function and Skin Hydration, 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 4 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: finished, as of the sponsor's last update on 17 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Transepidermal Water Loss (TEWL) (time frame: Baseline and Weeks 1, 2, 3, and 4). 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 Sep 2026.