Official Title: “Efficacy of Desonide (Desonatetm) Gel 0.05% in Younger and Older Subjects With Atopic Dermatitis”

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.

Study Type: Interventional

Study Design: Treatment, Open Label, Single Group Assignment, Efficacy Study

Study Primary Completion Date: December 2007

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

Intervention(s) in this Clinical Trial

• Drug: 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 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

Primary Measures

• The change from Baseline to Week 4 (or end of treatment) in the IGA
  • Time Frame: 4 weeks
    Safety Issue?: No

Inclusion Criteria:

• 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 Criteria:

• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Months

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Wake Forest University

Overall Clinical Trial Officials and Contacts

Steve Feldman, MD Principal Investigator Wake Forest University  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00690833

Study ID Number: 00002928

ClinicalTrials.gov Identifier: NCT00690833

Health Authority: United States: Institutional Review Board