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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Subjects will use "Cetaphil Healing Ointment" on the diaper rash area with every diaper change
Young Skin MD
Coral Springs, Florida, United States
Product Efficacy
Product efficacy will be measured by Investigator's evaluation of skin's tactile smoothness, visual skin texture, and diaper dermatitis. Skin smoothness (tactile) and skin texture will be measured on a 10-point modified Griffith's scale, where 0 is the best possible condition and 9 is the worst possible condition, and diaper dermatitis will be measured on a 5-point scale, where 0 is the best possible condition and 4 is the worst possible condition. A decrease in scores indicates an improvement.
Time frame: Week 1, Week 3
Subject Satisfaction
To evaluate subject satisfaction using a Self-Assessment Questionnaire. Questionnaires will be tabulated; and the frequency and percentage of all response options will be reported for each question and time point. For questionnaire inquiries without baseline response data, a binomial (sign) test will be performed to test if the proportion of the combined designated favorable responses is equal to the combined designated unfavorable responses for each applicable question. A higher percentage of favorable responses with a significant p value indicates positive subject perceptions of the study treatment.
Time frame: Day 1, Week 1, Week 3
Product Tolerability
Product tolerability will be measured by Investigator's evaluation of dryness, peeling, and 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. A decrease in scores or lack of significant increase indicates tolerability/safety of the treatment product.
Time frame: Week 1, Week 3
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