Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
Purpose
The objective of this study is to evaluate the safety and efficacy of up to 26 weeks of treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat pediatric subjects (2 to 16 years and 11 months of age) with mild to moderate plaque psoriasis.
Condition
- Psoriasis Vulgaris
Eligibility
- Eligible Ages
- Between 2 Years and 16 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male or female 2 to 16 years and 11 months of age - Clinical diagnosis of stable mild to moderate plaque psoriasis
Exclusion Criteria
- Other forms of psoriasis - Hypercalcemia - Past history of kidney stones - Vitamin D deficiency - Other concomitant dermatological disease
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Calcitriol ointment |
|
More Details
- Status
- Completed
- Sponsor
- Galderma R&D