Trial Outcomes & Findings for Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis (NCT NCT00693693)
NCT ID: NCT00693693
Last Updated: 2018-09-10
Results Overview
Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
26 participants
Primary outcome timeframe
2 weeks
Results posted on
2018-09-10
Participant Flow
Participants were recruited from IRB approved advertising and the Dermatology Clinic.
Participant milestones
| Measure |
Ointment
topical hydrocortisone 17-butyrate 0.1% preparation ointment
|
Lipocream
topical hydrocortisone 17-butyrate 0.1% preparation lipocream
|
Cream
topical hydrocortisone 17-butyrate 0.1% preparation cream
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
9
|
|
Overall Study
COMPLETED
|
6
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Ointment
topical hydrocortisone 17-butyrate 0.1% preparation ointment
|
Lipocream
topical hydrocortisone 17-butyrate 0.1% preparation lipocream
|
Cream
topical hydrocortisone 17-butyrate 0.1% preparation cream
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
Baseline Characteristics
Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Cream
n=9 Participants
topical hydrocortisone 17-butyrate 0.1% cream applied twice daily
|
Ointment
n=7 Participants
topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily
|
Lipocream
n=9 Participants
topical hydrocortisone 17-butyrate 0.1% Lipocream applied twice daily
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
21 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 weeksAdherence measured by MEMS cap as the % of days that the two total prescribed doses were applied
Outcome measures
| Measure |
Cream
n=6 Participants
topical hydrocortisone 17-butyrate 0.1% cream applied twice daily to all areas of atopic dermatitis
|
Ointment
n=7 Participants
topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily to all areas of atopic dermatitis
|
Lipocream
n=8 Participants
topical hydrocortisone 17-butyrate 0.1% Lipocream applied twice daily to all areas of atopic dermatitis
|
|---|---|---|---|
|
Adherence to Locoid
|
.55 percentage of days
Standard Deviation .07
|
.60 percentage of days
Standard Deviation .07
|
.50 percentage of days
Standard Deviation .07
|
Adverse Events
Topical Hydrocortisone 17-butyrate 0.1% Cream
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Topical Hydrocortisone 17-butyrate 0.1% Ointment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Topical Hydrocortisone 17-butyrate 0.1% Lipocream
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Steven Feldman, MD, PhD
Wake Forest University Health Sciences
Phone: 336-716-3775
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place