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

Sponsor:	Wake Forest University
Information provided by:	Wake Forest University
ClinicalTrials.gov Identifier:	NCT00693693

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Adherence to Topical Hydrocortisone 17-Butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis

Resource links provided by NLM:

Drug Information available for: Hydrocortisone acetate Hydrocortisone Hydrocortisone 17-butyrate Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate

U.S. FDA Resources

Further study details as provided by Wake Forest University:

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
1: Experimental 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.
2: Experimental 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.
3: Experimental 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

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

More Information

No publications provided

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

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dermatitis, Atopic
Hydrocortisone
Skin Diseases
Immune System Diseases
Cortisol succinate
Pharmacologic Actions
Hypersensitivity
Genetic Diseases, Inborn

Therapeutic Uses
Hydrocortisone-17-butyrate
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Hydrocortisone acetate
Dermatologic Agents
Skin Diseases, Genetic
Dermatitis

ClinicalTrials.gov processed this record on November 27, 2009