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

Phase 1

• Conditions: Psoriasis; MedDRA version: 19.0Level: 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-BE
• Lead Sponsor: GALDERMA R&D, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-16
• Study Completion: 2018-05-29
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 54

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

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 16 years and 11 months of age) with plaque psoriasis.;Secondary Objective: As a secondary objective, calcitriol plasma concentrations will be assessed at several time points throughout the study duration in a subset of children 2 to 6 years and 11 months old.;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>- Serum albumin-adjusted calcium, urine calcium:creatinine ratio, phosphorus, and PTH<br>- Adverse Event;Timepoint(s) of evaluation of this end point: At each visit

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Ct (pre dose plasma concentration)<br>;Timepoint(s) of evaluation of this end point: At each visit