Efficacy, Safety, Preference and Response Duration of Clobex® Spray and Taclonex® Ointment in 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: NCT00437255 |
Recruitment Status :
Completed
First Posted : February 19, 2007
Last Update Posted : April 7, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Plaque Psoriasis | Drug: Clobetasol Propionate, 0.05% Drug: Calcipotriene and betamethasone dipropionate ointment | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 122 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | An Evaluation of the Efficacy, Safety, Preference and Duration of Response of Clobex® (Clobetasol Propionate) Spray and Taclonex® (Calcipotriene 0.05%/Betamethasone Dipropionate 0.064%) Ointment in Subjects With Stable Plaque Psoriasis |
Study Start Date : | August 2006 |
Actual Primary Completion Date : | June 2007 |
Actual Study Completion Date : | June 2007 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Clobex® Spray
|
Drug: Clobetasol Propionate, 0.05%
Topical, twice daily for 4 weeks
Other Name: Clobex® Spray |
Active Comparator: 2
Taclonex® Ointment
|
Drug: Calcipotriene and betamethasone dipropionate ointment
Topical, once daily
Other Name: Taclonex® Ointment |
- Overall Disease Severity [ Time Frame: End of treatment (Week 4) ]
- Tolerability assessments, incidence of adverse events [ Time Frame: Baseline, Weeks 1, 2, 4 and 8 ]
- Overall Disease Severity [ Time Frame: Weeks 1, 2 and 8 ]
- Investigator Global Assessment [ Time Frame: End of treatment (week 4) and Weeks 1, 2 and 8 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Moderate to severe psoriasis involving 3-20% of the body surface area
Exclusion Criteria:
- Subjects who have surface area involvement too large that would require more than 50 grams per week of Clobex® Spray or more than 100 grams per week of Taclonex® Ointment
- Subjects having psoriasis that involves the scalp, face, or groin

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): NCT00437255
United States, Minnesota | |
Minnesota Clinical Study Center | |
Fridley, Minnesota, United States, 55432 | |
United States, Texas | |
DermResearch, Inc. | |
Austin, Texas, United States, 78759 | |
J & S Studies, Inc. | |
Bryan, Texas, United States, 77802 | |
Baylor Research Institute | |
Dallas, Texas, United States, 75230 |
Study Director: | Ronald W Gottschalk, MD | Galderma Laboratories, LP |
Responsible Party: | Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P. |
ClinicalTrials.gov Identifier: | NCT00437255 |
Other Study ID Numbers: |
US10034 |
First Posted: | February 19, 2007 Key Record Dates |
Last Update Posted: | April 7, 2008 |
Last Verified: | April 2008 |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Betamethasone Betamethasone Valerate Betamethasone-17,21-dipropionate Betamethasone benzoate Clobetasol Calcipotriene |
Betamethasone sodium phosphate Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents |