A multicenter, randomized, double blind, parallel group, vehicle controlled, study of the safety and efficacy of calcitriol 3 mcg/g ointment applied twice daily for 8 weeks in pediatric subjects (2 to 12 years of age) with mild to moderate plaque psoriasis
- Conditions
- PsoriasisTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2014-001744-38-IT
- Lead Sponsor
- GALDERMA RESEARCH & DEVELOPMENT, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
- Male or female pediatric subjects (2 to 12 years of age, inclusive) at Screening.
- Clinical diagnosis of stable plaque psoriasis with an IGA score of 2 or 3 at Screening and Baseline.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Subjects with guttate psoriasis, erythrodermic psoriasis or active infection (i.e., an infection associated with fever, swollen lymph nodes, and/or signs of localized inflammation of tissue and/or joints) Note: allergic or vasomotor rhinitis is not exclusionary.
- Subject has hypercalcemia (serum albumin-adjusted calcium level above the upper normal range) at Screening.
- Subjects with known or suspected disorders of calcium metabolism.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method