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

Condition(s) targeted: Atopic Dermatitis

Intervention: topical desonide hydrogel 0.05% (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Wake Forest School of Medicine

Official(s) and/or principal investigator(s):
Steve Feldman, MD, Principal Investigator, Affiliation: Wake Forest School of Medicine

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: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The change from Baseline to Week 4 (or end of treatment) in the IGA

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

Minimum age: 3 Months. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Wake Forest University Health Sciences Dermatology, Winston Salem, North Carolina 27157, United States

Starting date: August 2007
Last updated: March 24, 2010