Diaper RashPhase 4NCT06015217

A Clinical Study to Assess the Efficacy and Safety of a Healing Ointment on Diaper Rash

A Phase 4 study testing "Cetaphil Healing Ointment" in people with Diaper Rash, run by Galderma R&D at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this clinical trial is to assess the efficacy and safety of a Healing Ointment in infants 2-24 months with mild to moderate diaper rash. The main question it aims to answer is: does a Healing Ointment improve skin texture and smoothness in infants with mild to moderate diaper dermatitis? Participants will… Read more about this study

Who is it for?: Ages 2 to 24 monthsHealthy volunteers can take part
Conditions the study is for: Diaper Rash
What is being tested?: "Cetaphil Healing Ointment"
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: 25 Aug 2023to 13 Dec 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 2 to 24 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

The subjects must meet all the following criteria to be eligible for the study:
Infant subjects aged 2 months to 24 months
Females and males
All Fitzpatrick skin types I-VI
All races and ethnicities
Subject diagnosed with mild-to-moderate diaper rash

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Subject with healthy immune systems
Willing to be photographed at each visit (optional)
Willing to abstain from use of any other topical diaper rash treatments (ointments, moisturizers, emollients, creams, and wipes) other than the assigned test product and skincare products that have been routinely used on the diaper area during the duration of the study
Willing to continue using regular brands of face/body cleanser and not to begin use of any new skincare products other than the test product for the duration of the study
Parent/legal guardian/legal guardians must be at least 18 years old and are willing and able to present proof of legal guardianship
Parent/legal guardian/legal guardian with ability to read, understand and give consent for participation in the study
Parent/legal guardians/legal guardians willing to sign a photography release form
Parent/legal guardian/guardian must agree to adhere to the procedures and requirements of the study and to report to the site on the day(s) and at the time(s) scheduled for the assessments

Who cannot join

The presence of any of the following exclusion criteria excluded a subject from enrollment in the study:
Subject diagnosed with severe diaper rash
History of allergy or hypersensitivity to any ingredient of the test product
Presence of any disease or lesions near or on the area to be treated, e.g.,
Inflammation, active, or chronic infection in or near the treatment area
Psoriasis, eczema, rosacea, atopic dermatitis, herpes zoster/herpes simplex, and acanthosis

Show all 20Show fewer

Scars or deformities
History of coexisting bacterial infections or medical conditions with uncontrolled gastrointestinal diseases and/or bowel movements
History of severe elastosis and/or excessive sun exposure that, in the opinion of the Investigator, could have affected the outcome of the study
Planning on having surgeries and/or invasive medical procedures during the course of the study
Treatment with chemotherapy, immunosuppressive agents, inhaled corticosteroids, immunomodulatory therapy (e.g., monoclonal antibodies or antiviral treatment for human immunodeficiency virus or hepatitis C)
Current use of topical corticosteroids, topical prescription, or oral antibiotics in the treatment area, or use within last 2 weeks
Current use of over-the counter topical medications for diaper rash
History of cancer or previous radiation near or on the treatment area
Human immunodeficiency virus positive or active hepatitis
Presence of dermal markings on or near the treatment area that, in the opinion of the Investigator, will interfere with the clinical assessments
Any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion (e.g., a chronic or relapsing, disease that may interfere with the outcome of the study)
Other condition preventing the subject from entering the study in the Investigator's opinion, (e.g., subjects failing baseline assessments, subjects not likely to avoid other cosmetic treatments in the treatment area, subjects anticipated to be unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result).
Study site personnel, close relatives of the study site personnel (e.g., parent/legal guardians, children, siblings, or spouse), or employees and close relatives of employees at the Sponsor company.
Participation in any interventional clinical study within 30 days of screening

Trial locations and contacts

1 site in 1 country.

United States1 site

Young Skin MD
Coral Springs, Florida, 33067

Other trials in United States

About this study

Official title: An Open-label Study to Assess Efficacy and Safety of a Healing Ointment When Used on Infants With Mild-to-moderate Diaper Rash

The goal of this clinical trial is to assess the efficacy and safety of a Healing Ointment in infants 2-24 months with mild to moderate diaper rash. The main question it aims to answer is:

does a Healing Ointment improve skin texture and smoothness in infants with mild to moderate diaper dermatitis? Participants will use a Healing Ointment on the diaper area with every diaper change, have the Investigator perform efficacy and tolerability assessments, and complete questionnaires regarding subject satisfaction.

Conditions: Diaper Rash
Being tested: "Cetaphil Healing Ointment"
Medical subject headings: Diaper Rash

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

"Cetaphil Healing Ointment"Drug
Subjects will use "Cetaphil Healing Ointment" on the diaper rash area with every diaper change

Study groups in NCT06015217
Study group	Role	What they receive
Treatment Group	Experimental	All subjects have mild to moderate diaper dermatitis and are given "Cetaphil Healing Ointment" to use with every diaper change. Receives: Drug: "Cetaphil Healing Ointment"

What is being measured

The primary outcome is the main question the study is designed to answer.

Skin Texture
Product efficacy will be measured by Investigator's evaluation of visual skin texture. Skin texture was measured on a 10-point modified Griffith's scale, where 0 is the best possible condition and 9 is the worst possible condition.
Measured: Week 1, Week 3
Skin Smoothness
Product efficacy will be measured by Investigator's evaluation of skin's tactile smoothness. Skin smoothness (tactile) was measured on a 10-point modified Griffith's scale, where 0 is the best possible condition and 9 is the worst possible condition.
Measured: Week 1, Week 3
Diaper Dermatitis
Product efficacy will be measured by Investigator's evaluation of diaper dermatitis. Diaper dermatitis was measured on a 5-point scale, where 0 is the best possible condition and 4 is the worst possible condition.
Measured: Week 1, Week 3

Secondary outcomes (6)

Subject Satisfaction
A Self-Assessment Questionnaire was used to evaluate subject satisfaction. Scale consisted of 5 questions at every follow-up visit and parents selected level of satisfaction for each question from/to strongly agree, agree, neither, disagree, and strongly disagree.
Measured: Day 1
Subject Satisfaction
A Self-Assessment Questionnaire was used to evaluate subject satisfaction. Scale consisted of 5 questions at every follow-up visit and parents selected level of satisfaction for each question from/to strongly agree, agree, neither, disagree, and strongly disagree.
Measured: Week 1
Subject Satisfaction
A Self-Assessment Questionnaire was used to evaluate subject satisfaction. Scale consisted of 5 questions at every follow-up visit and parents selected level of satisfaction for each question from/to strongly agree, agree, neither, disagree, and strongly disagree.
Measured: Week 3
Dryness
Product tolerability was measured by Investigator's evaluation of dryness on a 4-point analog scale, with half-point scores used as necessary to better describe the clinical condition, where 0 indicates parameter is not present and 3 indicates parameter is severe.
Measured: Week 1, Week 3
Peeling
Product tolerability was measured by Investigator's evaluation of peeling on a 4-point analog scale, with half-point scores used as necessary to better describe the clinical condition, where 0 indicates parameter is not present and 3 indicates parameter is severe.
Measured: Week 1, Week 3
Edema
Product tolerability was measured by Investigator's evaluation of edema on a 4-point analog scale, with half-point scores used as necessary to better describe the clinical condition, where 0 indicates parameter is not present and 3 indicates parameter is severe.
Measured: Week 1, Week 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Aug 202313 Dec 2023

First posted29 Aug 2023
Study start25 Aug 2023
Primary completion13 Dec 2023
Study completion13 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diaper RashStudies of the same condition, open and under way.
More trials run by Galderma R&DThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: This study only has a single group, and all subjects receive the same treatment.
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06015217
Sponsor's protocol ID: GLI.04.US.SL.027
Status last verified: Apr 2026
First submitted: 14 Aug 2023
Last updated: 12 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
Diaper Dermatitis
Recruiting
Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
Fecal Incontinence, Urinary Incontinence
Not yet recruiting
Breast Milk Versus Barrier Creams for Diaper Dermatitis in Children Aged 0-24 Months
Diaper Dermatitis
Recruiting
Probiotics for Diaper Dermatitis
Diaper Dermatitis

All Diaper Rash trials

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Study to Assess Efficacy and Safety of a Healing Ointment When Used on Infants With Mild-to-moderate Diaper Rash
ClinicalTrials.gov ID: NCT06015217
Acronym / sponsor ID: GLI.04.US.SL.027
Conditions: Diaper Rash
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: 25 Aug 2023 (actual)
Primary completion: 13 Dec 2023 (actual)
Study completion: 13 Dec 2023 (actual)
First posted: 29 Aug 2023 (actual)
Results: Posted 12 May 2026

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 assess the efficacy and safety of a Healing Ointment in infants 2-24 months with mild to moderate diaper rash. The main question it aims to answer is:

does a Healing Ointment improve skin texture and smoothness in infants with mild to moderate diaper dermatitis? Participants will use a Healing Ointment on the diaper area with every diaper change, have the Investigator perform efficacy and tolerability assessments, and complete questionnaires regarding subject satisfaction.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This study only has a single group, and all subjects receive the same treatment.

Arm	Type	Receives
Treatment Group	Experimental	Drug: "Cetaphil Healing Ointment"All subjects have mild to moderate diaper dermatitis and are given "Cetaphil Healing Ointment" to use with every diaper change.

Who may qualify

Ages: 2 to 24 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (14 listed)

The subjects must meet all the following criteria to be eligible for the study:

Key exclusion criteria (20 listed)

The presence of any of the following exclusion criteria excluded a subject from enrollment in 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
"Cetaphil Healing Ointment"Subjects will use "Cetaphil Healing Ointment" on the diaper rash area with every diaper change	Drug	Treatment Group

Primary outcome

Skin Texture
Time frame: Week 1, Week 3
Product efficacy will be measured by Investigator's evaluation of visual skin texture. Skin texture was measured on a 10-point modified Griffith's scale, where 0 is the best possible condition and 9 is the worst possible condition.
Skin Smoothness
Time frame: Week 1, Week 3
Product efficacy will be measured by Investigator's evaluation of skin's tactile smoothness. Skin smoothness (tactile) was measured on a 10-point modified Griffith's scale, where 0 is the best possible condition and 9 is the worst possible condition.
Diaper Dermatitis
Time frame: Week 1, Week 3
Product efficacy will be measured by Investigator's evaluation of diaper dermatitis. Diaper dermatitis was measured on a 5-point scale, where 0 is the best possible condition and 4 is the worst possible condition.

6 secondary outcomes

Subject Satisfaction
Time frame: Day 1
Subject Satisfaction
Time frame: Week 1
Subject Satisfaction
Time frame: Week 3
Dryness
Time frame: Week 1, Week 3
Peeling
Time frame: Week 1, Week 3
Edema
Time frame: Week 1, Week 3

Results and safety

Results posted to the registry on 12 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Group	26	15

Primary outcome: Skin Texture

Time frame: Week 1, Week 3. Mean (Standard Deviation). Unit: Score on a scale

Measure	Treatment Group n = 26
Baseline	1.8 (1.5)
Week 1	0.5 (0.9)
Week 3	0 (0)

Population analysed: Intent-to-Treat population was used for primary outcome.

Primary outcome: Skin Smoothness

Time frame: Week 1, Week 3. Mean (Standard Deviation). Unit: Score on a scale

Measure	Treatment Group n = 26
Baseline	2.6 (1.8)
Week 1	1.1 (1.5)
Week 3	0.4 (0.7)

Primary outcome: Diaper Dermatitis

Time frame: Week 1, Week 3. Mean (Standard Deviation). Unit: Score on a scale

Measure	Treatment Group n = 26
Baseline	2.4 (0.8)
Week 1	1.8 (0.9)
Week 3	0.7 (0.6)

Population analysed: Intent-to-treat population was used for primary outcome.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 weeks (i.e., from the study start to the study completion).. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Group	0 of 26 (0%)	1 of 26 (3.8%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Diaper Rash

Enrolling by invitation
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
Diaper Dermatitis
Recruiting
Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
Fecal Incontinence, Urinary Incontinence
Not yet recruiting
Breast Milk Versus Barrier Creams for Diaper Dermatitis in Children Aged 0-24 Months
Diaper Dermatitis
Recruiting
Probiotics for Diaper Dermatitis
Diaper Dermatitis

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.

Latanya Benjamin principal investigator

Young Skin

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing "Cetaphil Healing Ointment" in people with Diaper Rash, run by Galderma R&D at 1 site in United States.

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 14 inclusion and 20 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 12 May 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Skin Texture (time frame: Week 1, Week 3). 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?

On the ClinicalTrials.gov record for NCT06015217.

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 12 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.