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

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ClinicalTrials.gov Identifier: NCT00693693
Recruitment Status : Completed
First Posted : June 9, 2008
Results First Posted : March 17, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

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

Condition or disease Intervention/treatment 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

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis
Study Start Date : November 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008


Arm Intervention/treatment
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



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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT00693693     History of Changes
Other Study ID Numbers: 00000702
First Posted: June 9, 2008    Key Record Dates
Results First Posted: March 17, 2017
Last Update Posted: December 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
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
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Butyric Acid
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dermatologic Agents