Trial Outcomes & Findings for Study of the Efficacy of Cloderm® Cream in the Treatment of Moderate Plaque Psoriasis (NCT NCT01714544)
NCT ID: NCT01714544
Last Updated: 2014-07-23
Results Overview
The proportion of subjects who demonstrate an IGA score of clear (0) or almost clear (1).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
28 days
Results posted on
2014-07-23
Participant Flow
Participant milestones
| Measure |
Cloderm Cream
Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days
Cloderm Cream
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
57
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Cloderm Cream
Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days
Cloderm Cream
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study of the Efficacy of Cloderm® Cream in the Treatment of Moderate Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Cloderm Cream
n=60 Participants
Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days
Cloderm Cream
|
|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
60 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Intent to treat population, with LOCF for missing data
The proportion of subjects who demonstrate an IGA score of clear (0) or almost clear (1).
Outcome measures
| Measure |
Cloderm Cream
n=60 Participants
Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days
Cloderm Cream
|
|---|---|
|
Investigator's Global Assessment (IGA)
|
15 percentage of subjects
Interval 8.1 to 26.1
|
Adverse Events
Cloderm Cream
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
Results disclosure agreements
- Principal investigator is a sponsor employee No report, abstract, oral presentation, or publication proposed by the Investigator/Institution in regard to Study shall be presented or published without the prior written consent of the Sponsor. Sponsor reserves the right to comment on and delay the proposed report, abstract, oral presentation, or publication and to revise as necessary to protect confidential information or intellectual property.
- Publication restrictions are in place
Restriction type: OTHER