Status:
COMPLETED
Efficacy of Desonide (Desonatetm) Gel 0.05% in Younger and Older Subjects With Atopic Dermatitis
Lead Sponsor:
Wake Forest University
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
3+ years
Phase:
PHASE4
Brief Summary
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 (F...
Detailed Description
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
Eligibility Criteria
Inclusion
- 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 sign.
- Moisturizers will be allowed during the study as long as the use remains stable from screening/baseline throughout the study.
Exclusion
- 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 study.
- 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 risks.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00690833
Start Date
August 1 2007
End Date
November 1 2009
Last Update
September 10 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Wake Forest University Health Sciences Dermatology
Winston-Salem, North Carolina, United States, 27157