Plaque Psoriasis Study in Pediatric Subjects
- Conditions
- Plaque Psoriasis
- Interventions
- Drug: placebo comparator
- Registration Number
- NCT02186665
- Lead Sponsor
- Galderma R&D
- Brief Summary
The purpose of this study is to compare the safety, efficacy and calcium metabolism of up to 8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- Male or female 2 to 12 years of age
- Clinical diagnosis of stable mild to moderate plaque psoriasis
- Other forms of psoriasis
- Hypercalcemia
- Past history of kidney stones
- Vitamin D deficiency
- Other concomitant dermatological disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description calcitriol ointment calcitriol ointment calcitriol 3 mcg/g ointment placebo placebo comparator placebo comparator
- Primary Outcome Measures
Name Time Method Success of Investigator's Global Assessment (IGA) Baseline to Week 8 The number of subjects with a minimum improvement of 2 grades from baseline in the IGA score and a severity rating of 0 (clear) of 1 (almost clear) at Week 8 (LOCF).
The IGA was evaluated at each visit on the following 0 to 4 point scale:
0 - Clear: No signs of psoriasis except for residual hypopigmentation / hyperpigmentation
1. - Almost Clear: Just perceptible erythema, no induration, and no scaling
2. - Mild: Mild erythema, no induration, and mild or no scaling
3. - Moderate: Moderate erythema, mild induration, and mild or no scaling
4. - Severe: Severe erythema, moderate to severe induration, and scaling of any degree
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (34)
David Stoll, MD
🇺🇸Beverly Hills, California, United States
Center for Dermatology and Laser Surgery
🇺🇸Sacramento, California, United States
Dermatology Specialists Research
🇺🇸Louisville, Kentucky, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
RCMC Center for Dermatology at Linden Oaks
🇺🇸Rochester, New York, United States
Clinical Partners, LLC
🇺🇸Johnston, Rhode Island, United States
Dermatology and Laser Center of Charleston
🇺🇸Charleston, South Carolina, United States
DermResearch
🇺🇸Austin, Texas, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Scroll for more (24 remaining)David Stoll, MD🇺🇸Beverly Hills, California, United States