Efficacy of Desonide (Desonatetm) Gel 0.05% in Younger and Older Subjects With Atopic Dermatitis
This study has been completed.
Sponsor:
Wake Forest University
Information provided by:
Wake Forest University
ClinicalTrials.gov Identifier:
NCT00690833
First received: June 2, 2008
Last updated: March 24, 2010
Last verified: June 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atopic Dermatitis |
Drug: topical desonide hydrogel 0.05% |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy of Desonide (Desonatetm) Gel 0.05% in Younger and Older Subjects With Atopic Dermatitis |
Resource links provided by NLM:
Further study details as provided by Wake Forest University:
Primary Outcome Measures:
- The change from Baseline to Week 4 (or end of treatment) in the IGA [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 41 |
| Study Start Date: | August 2007 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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
|
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| Ages Eligible for Study: | 3 Months and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690833
Locations
| United States, North Carolina | |
| Wake Forest University Health Sciences Dermatology | |
| Winston Salem, North Carolina, United States, 27157 | |
Sponsors and Collaborators
Wake Forest University
Investigators
| Principal Investigator: | Steve Feldman, MD | Wake Forest University |
More Information
No publications provided
| Responsible Party: | Steve Feldman, MD, Wake Forest University Health Sciences |
| ClinicalTrials.gov Identifier: | NCT00690833 History of Changes |
| Other Study ID Numbers: | 00002928, 32426 |
| Study First Received: | June 2, 2008 |
| Last Updated: | March 24, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Desonide Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013