Efficacy of Desonide (Desonatetm) Gel 0.05% in Younger and Older Subjects With Atopic Dermatitis
Information source: Wake Forest University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atopic Dermatitis
Intervention: topical desonide hydrogel 0.05% (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Wake Forest University
Official(s) and/or principal investigator(s):
Steve Feldman, MD, Principal Investigator, Affiliation: Wake Forest University
The purpose of this research study is to better understand how this study drug works when
people use it to treat atopic dermatitis. Desonate has been approved by the US Food and Drug
Administration (FDA) for atopic dermatitis.
Official title: Efficacy of Desonide (Desonatetm) Gel 0.05% in Younger and Older Subjects With Atopic Dermatitis
Study design: Treatment, Open Label, Single Group Assignment, Efficacy Study
Primary outcome: The change from Baseline to Week 4 (or end of treatment) in the IGA
To assess the efficacy of a desonide hydrogel 0. 05% in both young children (age <13) and
older subjects (ages 13 and up) with mild to moderate atopic dermatitis
Minimum age: 3 Months.
Maximum age: N/A.
- Male or female, age 3 months or greater.
- Subjects must have diagnosis of mild to moderate atopic dermatitis by an investigator
(a 2 or 3 on the IGA scale).
- Subjects must have >2% BSA involvement to be enrolled.
- Informed consent of participation must be given by parent or guardian if he or she is
<7 years old. Children who are 7 to 18 years old will be given an assent form to
- Moisturizers will be allowed during the study as long as the use remains stable from
screening/baseline throughout the study.
- Known allergy or sensitivity to topical desonide hydrogel in the subject.
- Inability to complete all study-related visits.
- Introduction of any other prescription medication, topical or systemic, for atopic
dermatitis while participating in the study. Other than stable use of over the
counter non-medicated moisturizers, all other topical treatments for AD must be
stopped prior to study drug initiation. There will be no required washout for any
topical therapies. Stable use of systemic therapies may be continued throughout the
- Requiring >130 gm of cream in a 4 week period.
- Pregnant women and women who are breastfeeding are to be excluded. Women of
childbearing potential will be allowed to participate in the study, and these subjects
will be required to use at least one form of birth control. Use of desonide in
pregnant subjects is controversial and is only to be used when benefits outweigh the
Locations and Contacts
Wake Forest University Health Sciences Dermatology, Winston Salem, North Carolina 27157, United States
Starting date: August 2007
Ending date: September 2008
Last updated: June 2, 2008