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
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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 |
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 |
- 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, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, North Carolina | |
Wake Forest University Health Sciences Dermatology | |
Winston-Salem, North Carolina, United States, 27157 |
Principal Investigator: | Steve Feldman, MD, PhD | Wake Forest University Health Sciences |
Responsible Party: | Wake Forest University |
ClinicalTrials.gov Identifier: | NCT00693693 |
Other Study ID Numbers: |
IRB00000702 |
First Posted: | June 9, 2008 Key Record Dates |
Results First Posted: | March 17, 2017 |
Last Update Posted: | September 10, 2018 |
Last Verified: | August 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity |
Immune System Diseases Hydrocortisone Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Hydrocortisone hemisuccinate Hydrocortisone-17-butyrate Anti-Inflammatory Agents Dermatologic Agents |