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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Wake Forest School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00693693
First received: June 5, 2008
Last updated: June 11, 2008
Last verified: June 2008
  Purpose

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


Condition Intervention Phase
Atopic Dermatitis
Drug: hydrocortisone 17-butyrate 0.1% preparation ointment
Drug: hydrocortisone 17-butyrate 0.1% preparation cream
Drug: hydrocortisone 17-butyrate 0.1% preparation lipocream
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 Wake Forest School of Medicine:

Primary Outcome Measures:
  • The change over treatment in the IGA. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2006
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
topical hydrocortisone 17-butyrate 0.1% preparation ointment
Drug: hydrocortisone 17-butyrate 0.1% preparation ointment
Apply medication twice a day to affected areas. Moisturize as needed.
Other Names:
  • Locoid cream
  • Locoid foam
  • Locoid ointment
Experimental: 2
topical hydrocortisone 17-butyrate 0.1% preparation cream
Drug: hydrocortisone 17-butyrate 0.1% preparation cream
Apply medication twice a day to affected areas. Moisturize as needed.
Experimental: 3
topical hydrocortisone 17-butyrate 0.1% preparation lipocream
Drug: hydrocortisone 17-butyrate 0.1% preparation lipocream
Apply medication twice a day to affected areas. Moisturize as needed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 School of Medicine
Investigators
Principal Investigator: Steve Feldman, MD, PhD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Steven Feldman, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00693693     History of Changes
Other Study ID Numbers: 00000702
Study First Received: June 5, 2008
Last Updated: June 11, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dermatitis, Atopic
Dermatitis
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on September 22, 2014