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

Completed · Phase 2

Conditions studied: Chronic Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT00419666

Run by

Galderma R&D

People needed

25

Starts

2006-08-01

Expected to finish

2009-09-24

Last updated by the study team

2021-02-18

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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