Status:
TERMINATED
The Healthy Baby Bottoms Study
Lead Sponsor:
Linda Fu
Collaborating Sponsors:
Avadim Technologies, Inc.
Conditions:
Diaper Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Diaper dermatitis is one of the most common dermatologic diseases affecting infants and children. The incidence is highest among those 9-12 months old and it has been reported to affect 7-50% of infan...
Eligibility Criteria
Inclusion
- Read English at the 8th grade level
- Have reliable access to email for 7 weeks
- Complete the first online survey within 24 hours of the request
- Custodial guardian of an infant between the ages of 1-12 months old living with him/her, wearing diapers, and has had ≥1 diaper rash in the 2 months preceding recruitment
Exclusion
- Does not have a stable address at which to receive a package of Theraworx and is unable/unwilling to pick it up at Children's National Health System
- Infant is immunocompromised, has a congenital disorder, or on the day of recruitment, has a diaper rash, has a moderate to severe illness requiring hospitalization or transfer to the emergency room, or was circumcised \<10 days prior.
Key Trial Info
Start Date :
March 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04101890
Start Date
March 12 2020
End Date
January 2 2021
Last Update
December 17 2021
Active Locations (1)
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1
Chidlren's National Hospital
Washington D.C., District of Columbia, United States, 20010