The Healthy Baby Bottoms Study
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|ClinicalTrials.gov Identifier: NCT04101890|
Recruitment Status : Terminated (Principal Investigator left the Institution and decision was made by funders to terminate the trial.)
First Posted : September 24, 2019
Results First Posted : December 17, 2021
Last Update Posted : December 17, 2021
|Condition or disease||Intervention/treatment||Phase|
|Diaper Dermatitis||Drug: Diaper care with Theraworx||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Healthy Baby Bottoms Study: A Trial of Theraworx Foam Formulation for the Prevention and Treatment of Diaper Dermatitis|
|Actual Study Start Date :||March 12, 2020|
|Actual Primary Completion Date :||January 2, 2021|
|Actual Study Completion Date :||January 2, 2021|
Experimental: Diaper care with Theraworx
Participants will be given a 4 week supply of Theraworx Spray Foam, an FDA-registered OTC drug (NDC 61594-000), to apply a thin layer to their infant's entire diaper area with every diaper change (2-4 foam pumps or 4-6 sprays depending on the infant's size) for 4 weeks.
Drug: Diaper care with Theraworx
Theraworx foam formulation to be used as a preventive and treatment agent for diaper rashes
No Intervention: Routine diaper care
Participants continue their typical diaper care.
- Caregiver's Self-report of Prevention of Diaper Dermatitis in Infant [ Time Frame: 4 weeks ]Caregivers self-report on a weekly basis the total number of days during the past week that their infant had a diaper rash. Diaper rash was defined as the presence of one or more of the following in the diaper region: redness, skin breakdown, papules or pustules. The total number of days with diaper rash for the entire 4 week period was summed from the 4 weekly surveys (outcome measure range: 0-28 days with fewer days representing a better outcome).
- Caregiver's Self-report of Diaper Rash Severity [ Time Frame: 4 weeks ]Caregivers used a modified Diaper Dermatitis Scale (Buckley, et al, Pediatric Dermatology 2016) to report infant diaper rash severity. The scale ranged from 0 (none) to 6 (most severe) with higher scores indicating a worse outcome. Items on the scale included assessments of rash size (0-2), redness (0-1), evidence of skin breakdown (0-1), evidence of papules (0-1) and evidence of pustules (0-1). Mean score was calculated using scores for every day over 28 days.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04101890
|United States, District of Columbia|
|Chidlren's National Hospital|
|Washington, District of Columbia, United States, 20010|