Efficacy and Safety of Calcipotriene/Betamethasone Gel/Ointment in Psoriasis
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|ClinicalTrials.gov Identifier: NCT00279162|
Recruitment Status : Completed
First Posted : January 19, 2006
Last Update Posted : March 26, 2015
Patients will receive either a gel containing both calcipotriene plus betamethasone or gel with no active ingredients as treatment for their scalp psoriasis for 8 weeks. After this time all patients will receive the gel containing both calcipotriene and betamethasone for 44 weeks. In addition, patients will receive an ointment containing both calcipotriene plus betamethasone as treatment for their psoriasis of the trunk and limbs for 52 weeks.
The objective is to study the short-term efficacy of the gel, and the short and long-term safety of the gel and the ointment.
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: Calcipotriene/betamethasone gel and ointment||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Calcipotriene Plus Betamethasone Dipropionate Gel Compared to the Gel Vehicle in Scalp Psoriasis, in Patients Receiving Calcipotriene Plus Betamethasone Dipropionate Ointment for Psoriasis Vulgaris of Trunk/Limbs|
|Study Start Date :||December 2005|
|Actual Study Completion Date :||July 2007|
- To compare the efficacy (in terms of patients with clear or minimal disease) of 8 weeks treatment with combination (calcipotriene plus betamethasone dipropionate) gel with that of the gel vehicle in scalp psoriasis.
- To compare the safety of 8 weeks treatment with combination gel with that of the gel vehicle in scalp psoriasis.
- To evaluate the efficacy and safety of 4 weeks treatment with combination ointment in psoriasis vulgaris of trunk/limbs.
- To evaluate the safety of 52 weeks treatment (used when required) with combination gel in scalp psoriasis.
- To evaluate the safety of 52 weeks treatment (used when required) with combination ointment in psoriasis vulgaris of trunk/limbs.
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): NCT00279162
|United States, Texas|
|Center for Clinical Studies|
|Houston, Texas, United States, 77058|
|Principal Investigator:||S Tyring, MD||Center for Clinical Studies|