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: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

• Drug: Calcitriol
  • BID

Primary Measures

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

Secondary Measures

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

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

Lead Sponsor: Galderma

Overall Clinical Trial Officials and Contacts

Michael Graeber, MD Study Director Galderma  

Overall Contact: Joyce Hwa, RN 609-860-8235 joyce.hwa@galderma.com

Information obtained from ClinicalTrials.gov on August 29, 2008

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