A Clinical Study to Assess the Efficacy and Safety of a Healing Ointment on Diaper Rash (NCT06015217) | Clinical Trial Compass
CompletedPhase 4
A Clinical Study to Assess the Efficacy and Safety of a Healing Ointment on Diaper Rash
United States26 participantsStarted 2023-08-25
Plain-language 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.
Who can participate
Age range2 Months – 24 Months
SexALL
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Inclusion criteria
✓. 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
✓. 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
Exclusion criteria
✕. 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