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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 : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Tracking Information
First Submitted Date  ICMJE June 5, 2008
First Posted Date  ICMJE June 9, 2008
Results First Submitted Date  ICMJE January 27, 2017
Results First Posted Date  ICMJE March 17, 2017
Last Update Posted Date September 10, 2018
Study Start Date  ICMJE November 2006
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
Adherence to Locoid [ Time Frame: 2 weeks ]
Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2008)
The change over treatment in the IGA. [ Time Frame: 2 weeks ]
Change History Complete list of historical versions of study NCT00693693 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis
Official Title  ICMJE Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis
Brief Summary The purpose of this research study is to better understand adherence to Locoid when people use it to treat atopic dermatitis.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Drug: hydrocortisone 17-butyrate 0.1% Cream preparation
    Apply medication twice a day to affected areas of atopic dermatitis
    Other Name: Locoid
  • Drug: hydrocortisone 17-butyrate 0.1% Ointment preparation
    Apply medication twice a day to affected areas of atopic dermatitis
    Other Name: locoid
  • Drug: hydrocortisone 17-butyrate 0.1% Lipocream preparation
    Apply medication twice a day to affected areas of atopic dermatitis
    Other Name: locoid
Study Arms  ICMJE
  • Active Comparator: Cream-
    topical hydrocortisone 17-butyrate 0.1% Cream preparation applied twice daily to all lesions of atopic dermatitis
    Intervention: Drug: hydrocortisone 17-butyrate 0.1% Cream preparation
  • Active Comparator: Ointment
    topical hydrocortisone 17-butyrate 0.1% Ointment preparation applied twice daily to all lesions of atopic dermatitis
    Intervention: Drug: hydrocortisone 17-butyrate 0.1% Ointment preparation
  • Active Comparator: Lipocream
    topical hydrocortisone 17-butyrate 0.1% Lipocream preparation applied twice daily to all lesions of atopic dermatitis
    Intervention: Drug: hydrocortisone 17-butyrate 0.1% Lipocream preparation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2017)
26
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2008)
30
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00693693
Other Study ID Numbers  ICMJE IRB00000702
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences ( Wake Forest University )
Study Sponsor  ICMJE Wake Forest University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steve Feldman, MD, PhD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP