A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis

NCT ID: NCT00419666

Last Updated: 2021-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-01
• Study Completion Date: 2009-09-24

Brief Summary

This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied twice daily to involved skin (10 - 35% BSA involved, excluding face, scalp and intertriginous areas) for 56 days (8 weeks). Full Pharmacokinetic (PK) and Pharmacodynamic (PD) profile will be collected during the first 3 weeks of the study; safety and efficacy data will be collected for the 8 weeks of the treatment.

Conditions

Chronic Plaque Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Calcitriol 3mcg/g

Participants receive calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.

Group Type: EXPERIMENTAL

Calcitriol 3mcg/g

Intervention Type: DRUG

Calcitriol 3mcg/g ointment applied twice daily for 56 weeks.

Interventions

Calcitriol 3mcg/g

Calcitriol 3mcg/g ointment applied twice daily for 56 weeks.

Intervention Type: DRUG

Other Intervention Names

CD2027; Vectical

Eligibility Criteria

Inclusion Criteria

• Diagnosis of chronic plaque psoriasis
• 10 - 35% BSA of involved skin
• Age 12 - 17

Exclusion Criteria

• Other type of psoriasis (other than plaque)
• Significant abnormal lab findings
• Vit D insufficiency

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Graeber, MD

Role: STUDY_DIRECTOR

Galderma R&D

Locations

Dermatology Research of Arkansas

Little Rock, Arkansas, United States

Children's Hospital, Department of Pediatric and Adolescent Dermatology

San Diego, California, United States

Dermatology Center For Children & Young Adults

Eagan, Minnesota, United States

University of Texas-Houston Medical Center Dept of Dermatology

Houston, Texas, United States

Center for Clinical Studies

Webster, Texas, United States

Nexus Clinical Research

St. John's, Newfoundland and Labrador, Canada

Newlab Clinical Research, Inc.

St. John's, Newfoundland and Labrador, Canada

Countries

United States; Canada

Other Identifiers

RD.06.SPR.18102

Identifier Type: -

Identifier Source: org_study_id