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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven R. Feldman, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT00693693
First received: June 5, 2008
Last updated: March 22, 2017
Last verified: March 2017
  Purpose
The purpose of this research study is to better understand adherence to Locoid when people use it to treat atopic dermatitis.

Condition Intervention Phase
Atopic Dermatitis
Drug: hydrocortisone 17-butyrate 0.1% Cream preparation
Drug: hydrocortisone 17-butyrate 0.1% Ointment preparation
Drug: hydrocortisone 17-butyrate 0.1% Lipocream preparation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Steven R. Feldman, Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Adherence to Locoid [ Time Frame: 2 weeks ]
    Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied


Enrollment: 26
Study Start Date: November 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cream-
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
Apply medication twice a day to affected areas of atopic dermatitis
Other Name: Locoid
Active Comparator: Ointment
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
Apply medication twice a day to affected areas of atopic dermatitis
Other Name: locoid
Active Comparator: Lipocream
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
Apply medication twice a day to affected areas of atopic dermatitis
Other Name: locoid

Detailed Description:

An investigator-blinded prospective study of subjects with mild to moderate atopic dermatitis (>5% Body Surface area and 2 or 3 on the Investigator Global Assessment (IGA) scale). The drug will be used within FDA-approved labeling. Subjects will be randomized to each of the following topical hydrocortisone 17-butyrate 0.1% preparations— ointment, cream or lipocream— in the manufacturer's original tube fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened and this data can be downloaded and tabulated with the associated software.

The study will consist of a 2-week Treatment Phase (visits at Baseline and Week 2). Subjects will be instructed to apply the medication twice daily (morning and evening) for 2 weeks to all of their AD lesions.

Adherence will be measured by MEMs cap.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00693693

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, PhD Wake Forest University Health Sciences
  More Information

Responsible Party: Steven R. Feldman, Professor of Dermatology, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00693693     History of Changes
Other Study ID Numbers: 00000702
Study First Received: June 5, 2008
Results First Received: January 27, 2017
Last Updated: March 22, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone
Hydrocortisone-17-butyrate
Butyric Acid
Anti-Inflammatory Agents
Dermatologic Agents
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017