Trial Outcomes & Findings for The Healthy Baby Bottoms Study (NCT NCT04101890)

Last Updated: 2021-12-17

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

4 weeks

Results posted on

2021-12-17

Participant Flow

All participants completed routine diaper care during the run-in period, followed by diaper care with Theraworx during the experimental period.

Participant milestones

Participant milestones
Measure	Routine Diaper Care Followed by Diaper Care With Theraworx Participants continue their typical diaper care for a period of 4 weeks. This is directly followed by 4 weeks 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).
Routine Diaper Care STARTED	5
Routine Diaper Care COMPLETED	5
Routine Diaper Care NOT COMPLETED	0
Diaper Care With Theraworx STARTED	5
Diaper Care With Theraworx COMPLETED	5
Diaper Care With Theraworx NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Healthy Baby Bottoms Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Routine Diaper Care Followed by Diaper Care With Theraworx n=5 Participants Participants continue their typical diaper care for 4 weeks followed immediately by 4 weeks of using Theraworx Spray Foam, an FDA-registered OTC drug (NDC 61594-000). During this second period, particpants 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. Diaper care with Theraworx: Theraworx foam formulation to be used as a preventive and treatment agent for diaper rashes
Age, Continuous	7 months n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Frequency of diaper rash in last 30 days, continuous	7 days n=93 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	Routine Diaper Care Followed by Diaper Care With Theraworx n=5 Participants Participants continue their typical diaper care x4 weeks, immediately followed by a 4 week period of using Theraworx Spray Foam, an FDA-registered OTC drug (NDC 61594-000). During this second period, particpants 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.
Caregiver's Self-report of Prevention of Diaper Dermatitis in Infant Routine Diaper Care	3.7 days Standard Deviation 2.5
Caregiver's Self-report of Prevention of Diaper Dermatitis in Infant Diaper care with Theraworx	1.7 days Standard Deviation 1.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Routine Diaper Care Followed by Diaper Care With Theraworx n=5 Participants Participants continue their typical diaper care x4 weeks, immediately followed by a 4 week period of using Theraworx Spray Foam, an FDA-registered OTC drug (NDC 61594-000). During this second period, particpants 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.
Caregiver's Self-report of Diaper Rash Severity Routine Diaper Care	4.45 score on a scale Standard Deviation 3.35
Caregiver's Self-report of Diaper Rash Severity Diaper Care with Theraworx	3.15 score on a scale Standard Deviation 3.82

Adverse Events

Diaper Care With Theraworx

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Routine Diaper Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elena Gibson

Children's Research Institute

Phone: (202) 476-6877

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place