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

NCT ID: NCT02125279

Last Updated: 2021-02-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2018-05-31

Brief Summary

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The objective of this study is to evaluate the safety and efficacy 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 mild to moderate plaque psoriasis.

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Detailed Description

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Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Calcitriol ointment

Group Type EXPERIMENTAL

Calcitriol

Intervention Type DRUG

Interventions

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Calcitriol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female 2 to 16 years and 11 months of age
* Clinical diagnosis of stable mild to moderate plaque psoriasis

Exclusion Criteria

* Other forms of psoriasis
* Hypercalcemia
* Past history of kidney stones
* Vitamin D deficiency
* Other concomitant dermatological disease
Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Graeber, MD

Role: STUDY_DIRECTOR

Galderma R&D, LLC

Locations

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Johnson Dermatology

Fort Smith, Arkansas, United States

Site Status

Northwest Arkansas Clinical Trials Center, PLLC

Rogers, Arkansas, United States

Site Status

Advanced Skincare Surgery & Medcenter

Burbank, California, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Shideler Clinical Research Center

Carmel, Indiana, United States

Site Status

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, United States

Site Status

Montefiore Medical Center

New York, New York, United States

Site Status

Arlington Research Center for Dermatology

Arlington, Texas, United States

Site Status

UZ Gent Dermatology Department

Ghent, , Belgium

Site Status

Lynderm Research Inc.

Markham, Ontario, Canada

Site Status

CHU Sainte-Justine

Montreal, Quebec, Canada

Site Status

Charité Universitätsmedizin Berlin

Berlin, , Germany

Site Status

University Hospital Carl Gustav Carus

Dresden, , Germany

Site Status

Universitäts-Hautklinik Mainz, Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Site Status

Padova University Hospital

Padua, , Italy

Site Status

University of Parma

Parma, , Italy

Site Status

Countries

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United States Belgium Canada Germany Italy

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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RD.06.SPR.18131

Identifier Type: -

Identifier Source: org_study_id

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