Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis

NCT00693693 | Completed Phase 4 Results

• 1 other identifier: IRB00000702
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to better understand adherence to Locoid when people use it to treat atopic dermatitis.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Adherence to Locoid

  Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied

  2 weeks

Study Arms (3)

Cream-

ACTIVE COMPARATOR

topical hydrocortisone 17-butyrate 0.1% Cream preparation applied twice daily to all lesions of atopic dermatitis

Drug: hydrocortisone 17-butyrate 0.1% Cream preparation

Ointment

ACTIVE COMPARATOR

topical hydrocortisone 17-butyrate 0.1% Ointment preparation applied twice daily to all lesions of atopic dermatitis

Drug: hydrocortisone 17-butyrate 0.1% Ointment preparation

Lipocream

ACTIVE COMPARATOR

topical hydrocortisone 17-butyrate 0.1% Lipocream preparation applied twice daily to all lesions of atopic dermatitis

Drug: hydrocortisone 17-butyrate 0.1% Lipocream preparation

Interventions

hydrocortisone 17-butyrate 0.1% Cream preparation DRUG

Apply medication twice a day to affected areas of atopic dermatitis

Also known as: Locoid

Cream-

hydrocortisone 17-butyrate 0.1% Ointment preparation DRUG

Apply medication twice a day to affected areas of atopic dermatitis

Also known as: locoid

Ointment

hydrocortisone 17-butyrate 0.1% Lipocream preparation DRUG

Apply medication twice a day to affected areas of atopic dermatitis

Also known as: locoid

Lipocream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years of age.
• Subjects must have diagnosis of mild to moderate atopic dermatitis using IGA criteria. (2 or 3 on severity scale)
• Subjects must have \>5% TBSA and \<30% to be enrolled.
• Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.

You may not qualify if:

• Known allergy or sensitivity to topical Locoid® cream, ointment or lipocream 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.
• Requiring \>130 gm of cream in a 2 week period.
• Having facial or groin involvement of their disease.
• Pregnant women and women who are breast feeding are to be excluded. Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.

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

Interventions

hydrocortisone-17-butyrate

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

336-716-3775

Study Officials

• Steve Feldman, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: June 9, 2008
• Study Start: November 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: September 10, 2018
• Results First Posted: March 17, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)