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:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT00219466
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female children, 2-36 months of age
* Wear diapers 24 hours per day
* Present to the test facility for enrollment at baseline with diaper rash receiving an "Overall Severity Score" greater than or equal to 1.5 as determined by the trained evaluator
* Parent/guardian signed informed consent
* Parent/guardian willing to use only the test product in the diaper area during the trial
* Parent/guardian willing to ensure that their child continues to wear their usual brand of diapers and will continue to clean their child during diaper changes using their usual products and method with the exception of ointments, lotions, creams or powders during the trial
* Parent/guardian is willing to refrain from changing any other products whose use may have an effect on their child's skin condition during the trial, i.e., laundry detergents, fabric softeners, and products used to bathe the child
* A Fitzpatrick Skin Type of I-IV
Exclusion Criteria:
* Illness within 4 days preceding enrollment
* Currently being toilet trained
* Active dermatological conditions other than diaper rash that may affect trial results
* History of recurrent dermatological conditions other than diaper rash that may affect trial results
* Concomitant use of medications that may affect trial results
* Known sensitivity to ingredients in trial medications
* Known sensitivity, rash or other abnormal skin reaction to topical or systemic medications or cleansing products within one year of trial initiation
* Other severe acute or chronic medical conditions that may increase the risk associated with trial participation or may interfere with the interpretation of results
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
36 Months
Study:
NCT00219466
Study Brief:
Protocol Section:
NCT00219466