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OpenTrials
Completed

NCT Number: NCT00690833

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.

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Key information

Age range

3 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, 27157, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

topical desonide hydrogel 0.05%

Drug

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

Other names: Desonide gel

Primary outcomes

  1. Investigator Global Assessment at Week 4

    Time frame: Week 4

    The Investigator global assessment at Week 4 is based on an overall scale of 0-4 with 0 being clear and 4 being very severe

Sponsors and collaborators

Lead sponsor

Wake Forest University

Other

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2009
First posted
Jun 5, 2008
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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