Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-26 @ 2:38 PM
NCT ID:
NCT02299206
Eligibility Criteria:
Inclusion Criteria:
* Healthy children (except for diaper dermatitis) between 3 and 18 months of age
* Wearing diapers 24 hours per day
* Clinical irritant diaper dermatitis
* Received a Diaper Dermatitis severity score of 1.0 to 2.0 by investigator at screening visit (mild-moderate severity)
* Parent/caregiver will not change type or brand of diaper during the study, although the diaper type will be recorded
* No alteration of current product usage for creams, lotions, ointments, powders, soap, laundry detergents, and fabric softeners
* A parent or guardian of minors must sign the approved Institutional Review Board consent form prior to the conduct of any study-related procedures
Exclusion Criteria:
* Illness within past 4 days before study enrollment or any medical condition that may affect risk of study participation
* Does not wear diapers 24 hours per day or currently being toilet trained
* Active diagnosis or history of dermatological conditions other than diaper rash that may affect study
* Concomitant use of medications that may affect study (e.g., antifungal, topical steroid, or topical calcineurin inhibitor)
* Previous allergic reaction or known sensitivity to ingredients in study agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
18 Months
Study:
NCT02299206
Study Brief:
Protocol Section:
NCT02299206