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

Verified by: Galderma, April 2011
First Received: January 5, 2007 | Last Updated: April 18, 2011 | Phase: Phase 2 | Start Date: August 2006
Overall Status: Completed | Estimated Enrollment: 25
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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...

Brief Summary

Official Title: “PK and PD of Calcitriol Following Twice Daily Application of Calcitriol 3 µg/g Ointment Under Conditions of Maximal Use in Adolescents With Plaque Psoriasis”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: September 2009

Intervention(s) in this Clinical Trial

  • Drug: Calcitriol
    • BID

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Calcitriol

Outcome Measures for this Clinical Trial

Primary Measures

  • PK
    • Time Frame: 0, 1, 3, 4, 6, 9
      Safety Issue?: No

Secondary Measures

  • PD
    • Time Frame: 0
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Galderma Industry

Overall Clinical Trial Officials and Contacts

Michael Graeber, MD Study Director Galderma  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00419666

Study ID Number: RD.06.SPR.18102

ClinicalTrials.gov Identifier: NCT00419666

Health Authority: United States: Food and Drug Administration

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