Diaper Rash
Conditions
Brief 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 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.
Interventions
DRUG"Cetaphil Healing Ointment"
Subjects will use "Cetaphil Healing Ointment" on the diaper rash area with every diaper change
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study only has a single group, and all subjects receive the same treatment.
Eligibility
Sex/Gender
ALL
Age
2 Months to 24 Months
Healthy volunteers
Yes
Inclusion criteria
* The subjects must meet all the following criteria to be eligible for the study: 1. Infant subjects aged 2 months to 24 months 2. Females and males 3. All Fitzpatrick skin types I-VI 4. All races and ethnicities 5. Subject diagnosed with mild-to-moderate diaper rash 6. Subject with healthy immune systems 7. Willing to be photographed at each visit (optional) 8. 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 9. 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 10. Parent/legal guardian/legal guardians must be at least 18 years old and are willing and able to present proof of legal guardianship 11. Parent/legal guardian/legal guardian with ability to read, understand and give consent for participation in the study 12. Parent/legal guardians/legal guardians willing to sign a photography release form 13. 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
Exclusion criteria
* The presence of any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Texture | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction | Day 1 | 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. |
| Dryness | Week 1, Week 3 | 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. |
| Peeling | Week 1, Week 3 | 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. |
| Edema | Week 1, Week 3 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLatanya Benjamin
Young Skin
Participant flow
Pre-assignment details
26 subjects met the inclusion and exclusion criteria, and were enrolled in the study
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 10.7 Months STANDARD_DEVIATION 7.4 |
| Race/Ethnicity, Customized African American | 6 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Hispanic/Latin American | 8 Participants |
| Race/Ethnicity, Customized White/Caucasian | 11 Participants |
| Region of Enrollment United States | 26 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 1 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
None listed