ong Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis

Phase 1

• Conditions: Psoriasis; MedDRA version: 20.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-000710-53-DE
• Lead Sponsor: GALDERMA R&D, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-28
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

- Male or female 2 to 16 years and 11 months at Screening.

- The subject has a clinical diagnosis of stable mild to moderate plaque type psoriasis.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
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, pustular 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).

- 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