A multicenter open label uncontrolled study of the long term safety and efficacy of calcitriol 3 mcg/g ointment applied twice daily for 26 weeks in pediatric subjects (2 to 17 years of age) with mild to moderate plaque psoriasis

Phase 1

Conditions: Psoriasis
MedDRA version: 18.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2014-000710-53-IT

Lead Sponsor: GALDERMA R&D, LLC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 140

Inclusion Criteria

- Male or female pediatric subjects (2 to 17 years of age, inclusive) 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: 140
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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety 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 17 years of age) with plaque psoriasis.;Secondary Objective: Not applicable;Primary end point(s): Efficacy endpoints:<br>- Percentage of subjects with an IGA Score of 0 (clear) or 1 (almost clear).<br>- Change from Baseline in Pruritus. <br>- Change from Baseline in % BSA. <br>Safety endpoints:<br>- include Serum albumin-adjusted calcium, urine calcium:creatinine ratio, phosphorus, and PTH.;Timepoint(s) of evaluation of this end point: At each visit

Secondary Outcome Measures