Efficacy and Safety of Calcipotriene/Betamethasone Gel/Ointment in Psoriasis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- 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.
|Study Start Date:||December 2005|
|Study Completion Date:||July 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279162
|United States, Texas|
|Center for Clinical Studies|
|Houston, Texas, United States, 77058|
|Principal Investigator:||S Tyring, MD||Center for Clinical Studies|