Measuring Adherence to Topical Therapy in Children With Atopic Dermatitis and the Impact of a Return Visit

NCT00654355 | Completed Phase 4 Results

• 2 other identifiers: IRB00002300contract #32417
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to better understand how the study drug works when people use it to treat atopic dermatitis.

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; eczema

Outcome Measures

Primary Outcomes (1)

• Adherence

  adherence to topical therapy in children via MEMS cap in a "real-life" clinic population measured as the % of required applications completed

  Week 4

Secondary Outcomes (2)

• The % Change From Baseline to Week 4 (or End of Treatment) in the IGA.

  Week 4

• EASI

  Week 4

Study Arms (1)

Active Drug

EXPERIMENTAL

tacrolimus ointment

Drug: tacrolimus ointment

Interventions

tacrolimus ointment DRUG

tacrolimus ointment to be applied twice daily to affected areas during duration of study

Also known as: Protopic Ointment

Active Drug

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female subjects age 2-15.
• Stable or worsening atopic dermatitis affecting 5% or greater body surface area. Face and genital areas can be included in the body surface area determination and treatment area.
• The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
• The ability to understand and sign a written informed consent/assent form, which must be obtained prior to treatment.

You may not qualify if:

• Known allergy to tacrolimus or to any component of the formulations.
• The use of systemic therapy for atopic dermatitis within the past 4 weeks.
• Use of prescription topical therapy for atopic dermatitis (e.g., corticosteroids or retinoids) within the past 2 weeks.
• Use of any investigational therapy within the past 4 weeks.
• Pregnant females, females who are breast feeding, or females of childbearing potential who are not practicing an acceptable method of birth control (abstinence, birth control pill/patch, barrier with spermicidal jelly, IUD, etc.), as determined by the investigator. Acceptable contraception must be used during the entire study. A pregnancy test will be performed on females of childbearing potential at baseline and at week 4.
• Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Dept of Dermatology, WFUHS

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

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: Steven Feldman, MD, PhD
• Organization: Wake Forest University Health Sciences

sfeldman@wfubmc.edu

336-716-3885

Study Officials

• Steve Feldman, MD, PHD

  WFUHS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: April 2, 2008
• First Posted: April 8, 2008
• Study Start: April 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: August 1, 2018
• Results First Posted: June 6, 2017

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)