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

Wake Forest University (WFU)

Status and phase: Completed; Phase 4

Conditions: Atopic Dermatitis

Treatments: Drug: topical desonide hydrogel 0.05%

Study type: Interventional

Funder types: Other

Identifiers

NCT00690833

IRB00002928

32426

Details and patient eligibility

About

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.

Full 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

Enrollment: 41 patients

Sex: All

Ages: 3+ months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

topical desonide hydrogel 0.05%

Experimental group

Description:

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

Treatment:

Drug: topical desonide hydrogel 0.05%