Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00658788 |
Recruitment Status :
Completed
First Posted : April 15, 2008
Results First Posted : August 27, 2014
Last Update Posted : August 27, 2014
|
Sponsor:
Galderma Laboratories, L.P.
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Psoriasis |
Interventions |
Drug: clobetasol propionate spray 0.05% Drug: calcitriol ointment |
Enrollment | 305 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Sequential Treatment Regimen |
---|---|
![]() |
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily |
Period Title: Overall Study | |
Started | 305 |
Completed | 231 |
Not Completed | 74 |
Reason Not Completed | |
Adverse Event | 11 |
Withdrawal by Subject | 13 |
Lost to Follow-up | 18 |
Treatment Discontinuation | 32 |
Baseline Characteristics
Arm/Group Title | Sequential Treatment Regimen | |
---|---|---|
![]() |
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily | |
Overall Number of Baseline Participants | 305 | |
![]() |
[Not Specified]
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||
Number Analyzed | 305 participants | |
48.6 (14.9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 305 participants | |
Female |
118 38.7%
|
|
Male |
187 61.3%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 305 participants | |
Hispanic or Latino |
27 8.9%
|
|
Not Hispanic or Latino |
278 91.1%
|
|
Unknown or Not Reported |
0 0.0%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 305 participants | |
American Indian or Alaska Native |
1 0.3%
|
|
Asian |
9 3.0%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
|
Black or African American |
10 3.3%
|
|
White |
273 89.5%
|
|
More than one race |
12 3.9%
|
|
Unknown or Not Reported |
0 0.0%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Elizabeth M Nieman |
Organization: | Galderma Laboratories, L.P. |
Phone: | 817-961-5000 |
EMail: | elizabeth.nieman@galderma.com |
Responsible Party: | Galderma Laboratories, L.P. |
ClinicalTrials.gov Identifier: | NCT00658788 |
Other Study ID Numbers: |
US10085 |
First Submitted: | March 4, 2008 |
First Posted: | April 15, 2008 |
Results First Submitted: | August 12, 2014 |
Results First Posted: | August 27, 2014 |
Last Update Posted: | August 27, 2014 |