Trial Outcomes & Findings for A Clinical Study to Assess the Efficacy and Safety of a Healing Ointment on Diaper Rash (NCT NCT06015217)
NCT ID: NCT06015217
Last Updated: 2026-05-12
Results Overview
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.
COMPLETED
PHASE4
26 participants
Week 1, Week 3
2026-05-12
Participant Flow
26 subjects met the inclusion and exclusion criteria, and were enrolled in the study
Participant milestones
| Measure |
Treatment Group
All subjects had mild to moderate diaper dermatitis and were given Cetaphil Healing Ointment to use. Parent applied the Healing Ointment liberally to the rash area with every diaper change. Reapply as needed throughout the day.
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|---|---|
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Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
15
|
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Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Study to Assess the Efficacy and Safety of a Healing Ointment on Diaper Rash
Baseline characteristics by cohort
| Measure |
Treatment Group
n=26 Participants
All subjects had mild to moderate diaper dermatitis and were given Cetaphil Healing Ointment to use. Parent applied the Healing Ointment liberally to the rash area with every diaper change. Reapply as needed throughout the day.
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|---|---|
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Age, Continuous
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10.7 Months
STANDARD_DEVIATION 7.4 • n=1512 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=1512 Participants
|
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Sex: Female, Male
Male
|
17 Participants
n=1512 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
11 Participants
n=1512 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latin American
|
8 Participants
n=1512 Participants
|
|
Race/Ethnicity, Customized
African American
|
6 Participants
n=1512 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=1512 Participants
|
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Region of Enrollment
United States
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26 Participants
n=1512 Participants
|
PRIMARY outcome
Timeframe: Week 1, Week 3Population: Intent-to-Treat population was used for primary outcome.
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.
Outcome measures
| Measure |
Treatment Group
n=26 Participants
All subjects have mild to moderate diaper dermatitis and are given "Cetaphil Healing Ointment" to use with every diaper change.
|
|---|---|
|
Skin Texture
Week 1
|
0.5 Score on a scale
Standard Deviation 0.9
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|
Skin Texture
Week 3
|
0 Score on a scale
Standard Deviation 0
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Skin Texture
Baseline
|
1.8 Score on a scale
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: Week 1, Week 3Product 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.
Outcome measures
| Measure |
Treatment Group
n=26 Participants
All subjects have mild to moderate diaper dermatitis and are given "Cetaphil Healing Ointment" to use with every diaper change.
|
|---|---|
|
Skin Smoothness
Baseline
|
2.6 Score on a scale
Standard Deviation 1.8
|
|
Skin Smoothness
Week 1
|
1.1 Score on a scale
Standard Deviation 1.5
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Skin Smoothness
Week 3
|
0.4 Score on a scale
Standard Deviation 0.7
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PRIMARY outcome
Timeframe: Week 1, Week 3Population: Intent-to-treat population was used for primary outcome.
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.
Outcome measures
| Measure |
Treatment Group
n=26 Participants
All subjects have mild to moderate diaper dermatitis and are given "Cetaphil Healing Ointment" to use with every diaper change.
|
|---|---|
|
Diaper Dermatitis
Baseline
|
2.4 Score on a scale
Standard Deviation 0.8
|
|
Diaper Dermatitis
Week 1
|
1.8 Score on a scale
Standard Deviation 0.9
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Diaper Dermatitis
Week 3
|
0.7 Score on a scale
Standard Deviation 0.6
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SECONDARY outcome
Timeframe: Day 1A 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.
Outcome measures
| Measure |
Treatment Group
n=9 Participants
All subjects have mild to moderate diaper dermatitis and are given "Cetaphil Healing Ointment" to use with every diaper change.
|
|---|---|
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Subject Satisfaction
Subjects reported they noticed instant relief on baby's irritated skin after applying the product
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6 Participants
|
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Subject Satisfaction
Subjects reported their baby's skin felt smooth
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7 Participants
|
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Subject Satisfaction
Subjects reported their baby's skin felt soft
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8 Participants
|
|
Subject Satisfaction
Subjects reported the product instantly soothed their baby's irritated skin
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7 Participants
|
SECONDARY outcome
Timeframe: Week 1A 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.
Outcome measures
| Measure |
Treatment Group
n=14 Participants
All subjects have mild to moderate diaper dermatitis and are given "Cetaphil Healing Ointment" to use with every diaper change.
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|---|---|
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Subject Satisfaction
Subjects reported the product did not feel greasy
|
12 Participants
|
|
Subject Satisfaction
Subjects reported their baby's skin felt softer and smoother
|
11 Participants
|
|
Subject Satisfaction
Subjects reported the product soothed their baby's skin
|
12 Participants
|
|
Subject Satisfaction
Subjects reported this product was gentle on my baby's delicate skin
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13 Participants
|
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Subject Satisfaction
Subjects reported the product was easy to wipe/wash off without leaving any greasy residue
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14 Participants
|
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Subject Satisfaction
Subjects reported the product lasted between diaper changes
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13 Participants
|
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Subject Satisfaction
Subjects reported the product did not leave the skin feeling greasy
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13 Participants
|
|
Subject Satisfaction
Subjects reported this product had started to repair their baby's irritated skin
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11 Participants
|
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Subject Satisfaction
Subjects reported this product provided a protective layer for their baby's skin
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13 Participants
|
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Subject Satisfaction
Subjects reported they noticed an immediate relief on their baby's skin
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9 Participants
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SECONDARY outcome
Timeframe: Week 3A 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.
Outcome measures
| Measure |
Treatment Group
n=15 Participants
All subjects have mild to moderate diaper dermatitis and are given "Cetaphil Healing Ointment" to use with every diaper change.
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|---|---|
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Subject Satisfaction
Subjects reported diaper rash flares were less frequent since starting this product
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10 Participants
|
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Subject Satisfaction
Subjects reported the product continuously protected their baby's skin from diaper rash
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12 Participants
|
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Subject Satisfaction
Subjects reported the product provided long-lasting diaper rash relief
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12 Participants
|
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Subject Satisfaction
Subjects reported they had enjoyed using this product on their baby
|
12 Participants
|
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Subject Satisfaction
Subjects reported their baby's skin quality had improved since starting this product
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11 Participants
|
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Subject Satisfaction
Subjects reported they loved how this product left their baby's skin feeling soft and soothed
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13 Participants
|
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Subject Satisfaction
Subjects reported their baby was less fussy since starting this product
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10 Participants
|
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Subject Satisfaction
Subjects reported diaper rash flares were less intense since starting this product
|
11 Participants
|
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Subject Satisfaction
Subjects reported they worried less about their baby's diaper rash since starting this product
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10 Participants
|
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Subject Satisfaction
Subjects reported their baby slept better since starting this product
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10 Participants
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SECONDARY outcome
Timeframe: Week 1, Week 3Population: Intent-to-Treat population was used for tolerability outcome.
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.
Outcome measures
| Measure |
Treatment Group
n=26 Participants
All subjects have mild to moderate diaper dermatitis and are given "Cetaphil Healing Ointment" to use with every diaper change.
|
|---|---|
|
Dryness
Week 1
|
0.1 Score on a scale
Standard Deviation 0.3
|
|
Dryness
Week 3
|
0 Score on a scale
Standard Deviation 0
|
|
Dryness
Baseline
|
0.5 Score on a scale
Standard Deviation 0.7
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SECONDARY outcome
Timeframe: Week 1, Week 3Population: Intent-to-Treat population was used for tolerability outcome.
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.
Outcome measures
| Measure |
Treatment Group
n=26 Participants
All subjects have mild to moderate diaper dermatitis and are given "Cetaphil Healing Ointment" to use with every diaper change.
|
|---|---|
|
Peeling
Baseline
|
0.1 Score on a scale
Standard Deviation 0.3
|
|
Peeling
Week 1
|
0.1 Score on a scale
Standard Deviation 0.3
|
|
Peeling
Week 3
|
0 Score on a scale
Standard Deviation 0
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SECONDARY outcome
Timeframe: Week 1, Week 3Population: Intent-to-Treat population was used for tolerability outcome.
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.
Outcome measures
| Measure |
Treatment Group
n=26 Participants
All subjects have mild to moderate diaper dermatitis and are given "Cetaphil Healing Ointment" to use with every diaper change.
|
|---|---|
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Edema
Baseline
|
0 Score on a scale
Standard Deviation 0.1
|
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Edema
Week 1
|
0 Score on a scale
Standard Deviation 0
|
|
Edema
Week 3
|
0 Score on a scale
Standard Deviation 0
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Adverse Events
Treatment Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Group
n=26 participants at risk
All subjects have mild to moderate diaper dermatitis and were given "Cetaphil Healing Ointment" to use with every diaper change.
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|---|---|
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Immune system disorders
Eczema Flare-Up
|
3.8%
1/26 • 3 weeks (i.e., from the study start to the study completion).
Throughout the course of the study, all adverse events were monitored and reported on an adverse event CRF/eCRF without omitting any requested and known information.
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|
Immune system disorders
Cold
|
3.8%
1/26 • 3 weeks (i.e., from the study start to the study completion).
Throughout the course of the study, all adverse events were monitored and reported on an adverse event CRF/eCRF without omitting any requested and known information.
|
|
General disorders
Miliaria rubra
|
3.8%
1/26 • 3 weeks (i.e., from the study start to the study completion).
Throughout the course of the study, all adverse events were monitored and reported on an adverse event CRF/eCRF without omitting any requested and known information.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place