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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | All subjects have mild to moderate diaper dermatitis and are given "Cetaphil Healing Ointment" to use with every diaper change. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Cetaphil Healing Ointment" | Drug | Subjects will use "Cetaphil Healing Ointment" on the diaper rash area with every diaper change |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Week 1, Week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Subject Satisfaction |
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Inclusion Criteria:
The subjects must meet all the following criteria to be eligible for the study:
Exclusion Criteria:
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.,
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
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| Name | Affiliation | Role |
|---|---|---|
| Latanya Benjamin | Young Skin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Young Skin MD | Coral Springs | Florida | 33067 | United States |
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26 subjects met the inclusion and exclusion criteria, and were enrolled in the study
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-Treat population was used for primary outcome. | Posted | Mean | Standard Deviation | Score on a scale | Week 1, Week 3 |
|
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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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | All subjects have mild to moderate diaper dermatitis and were given "Cetaphil Healing Ointment" to use with every diaper change. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold | Immune system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thu Q. Nguyen, PhD | Galderma | 8179615495 | thu.nguyen@galderma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2023 | Apr 16, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003963 | Diaper Rash |
| ID | Term |
|---|---|
| D017453 | Dermatitis, Irritant |
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
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This study only has a single group, and all subjects receive the same treatment.
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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. |
| 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. | 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. | 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. | 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. | Week 1, Week 3 |
| Months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Secondary | 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. | Posted | Count of Participants | Participants | Day 1 |
|
|
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| Secondary | 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. | Posted | Count of Participants | Participants | Week 1 |
|
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| Primary | 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. | Posted | Mean | Standard Deviation | Score on a scale | Week 1, Week 3 |
|
|
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| Primary | 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. | Intent-to-treat population was used for primary outcome. | Posted | Mean | Standard Deviation | Score on a scale | Week 1, Week 3 |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Week 3 |
|
|
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| Secondary | 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. | Intent-to-Treat population was used for tolerability outcome. | Posted | Mean | Standard Deviation | Score on a scale | Week 1, Week 3 |
|
|
|
| Secondary | 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. | Intent-to-Treat population was used for tolerability outcome. | Posted | Mean | Standard Deviation | Score on a scale | Week 1, Week 3 |
|
|
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| Secondary | 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. | Intent-to-Treat population was used for tolerability outcome. | Posted | Mean | Standard Deviation | Score on a scale | Week 1, Week 3 |
|
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| 0 |
| 26 |
| 0 |
| 26 |
| 1 |
| 26 |
| Miliaria rubra | General disorders | Systematic Assessment |
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| Eczema Flare-Up | Immune system disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
|
| Subjects reported their baby's skin felt soft |
|
| Title | Measurements |
|---|---|
|
| Subjects reported the product was easy to wipe/wash off without leaving any greasy residue |
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| Subjects reported the product lasted between diaper changes |
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| Subjects reported the product did not leave the skin feeling greasy |
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| Subjects reported this product was gentle on my baby's delicate skin |
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| Subjects reported this product had started to repair their baby's irritated skin |
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| Subjects reported this product provided a protective layer for their baby's skin |
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| Subjects reported they noticed an immediate relief on their baby's skin |
|
| Title |
|---|
| Measurements |
|---|
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| Week 3 |
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| Subjects reported diaper rash flares were less intense since starting this product |
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| Subjects reported they had enjoyed using this product on their baby |
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| Subjects reported their baby's skin quality had improved since starting this product |
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| Subjects reported they loved how this product left their baby's skin feeling soft and soothed |
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| Subjects reported their baby was less fussy since starting this product |
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| Subjects reported they worried less about their baby's diaper rash since starting this product |
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| Subjects reported their baby slept better since starting this product |
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| Week 3 |
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| Week 3 |
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| Week 3 |
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