EUCTR2014-001744-38-DE
Active, not recruiting
Phase 1
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 - Safety and Efficacy study of calcitriol 3 mcg/g ointment in pediatric subjects with plaque psoriasis
GALDERMA R&D, LLC0 sites300 target enrollmentStarted: October 28, 2014Last updated:
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- GALDERMA R&D, LLC
- Enrollment
- 300
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •\- 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: 300
- •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
Exclusion Criteria
- •\- 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.
Investigators
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