Trial Outcomes & Findings for Efficacy of Desonide (Desonatetm) Gel 0.05% in Younger and Older Subjects With Atopic Dermatitis (NCT NCT00690833)

Last Updated: 2018-09-10

Results Overview

The Investigator global assessment at Week 4 is based on an overall scale of 0-4 with 0 being clear and 4 being very severe

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

41 participants

Primary outcome timeframe

Week 4

Results posted on

2018-09-10

Participant milestones
Measure	Topical Desonide Hydrogel 0.05% Approximately 40 male and female subjects (about 20 age 3 months to \<13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions
Overall Study STARTED	41
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	2

Withdrawal data not reported

Efficacy of Desonide (Desonatetm) Gel 0.05% in Younger and Older Subjects With Atopic Dermatitis

Baseline characteristics by cohort
Measure	Topical Desonide Hydrogel 0.05% n=41 Participants Approximately 40 male and female subjects (about 20 age 3 months to \<13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions
Age, Continuous	13 years n=99 Participants
Sex: Female, Male Female	23 Participants n=99 Participants
Sex: Female, Male Male	18 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	19 Participants n=99 Participants
Race (NIH/OMB) White	17 Participants n=99 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United States	41 participants n=99 Participants

Timeframe: Week 4

The Investigator global assessment at Week 4 is based on an overall scale of 0-4 with 0 being clear and 4 being very severe

Outcome measures
Measure	Topical Desonide Hydrogel 0.05% n=41 Participants Approximately 40 male and female subjects (about 20 age 3 months to \<13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions
Investigator Global Assessment at Week 4	2.3 units on a scale Standard Deviation 0.5

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Wake Forest University Health Sciences

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