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

NCT00690833 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: IRB0000292832426
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Investigator Global Assessment at 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

  Week 4

Study Arms (1)

topical desonide hydrogel 0.05%

EXPERIMENTAL

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

Drug: topical desonide hydrogel 0.05%

Interventions

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

Also known as: Desonide gel

topical desonide hydrogel 0.05%

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr Steve feldman
• Organization: Wake Forest University Health Sciences

sfeldman@wakehealth.edu

336-716-3775

Study Officials

• Steve Feldman, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2008
• First Posted: June 5, 2008
• Study Start: August 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: November 1, 2009
• Last Updated: September 10, 2018
• Results First Posted: March 28, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)