Clinical trial NCT00419666: A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Plaque Psoriasis
Keywords: Calcitriol
Psoriasis
PK
Adolescents
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2007-01-09
Enrollment: 25
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Trough Plasma Levels (Ctrough) of Calcitriol
timeFrame: Day 0 (Baseline), Day 14, Day 21, and Day 56
measure: The Observed Peak Drug Concentration (Cmax) of Calcitriol
timeFrame: Day 0 (Baseline), Day 21
measure: Area Under the Concentration-Time Curve From Pre-Application (T0) Through 9 Hours Post Dosing (AUC [0-9 Hours])
timeFrame: 0 (predose) and 9 hours post dose on Day 0 (Baseline), Day 21
measure: Area Under the Concentration-Time Curve From Pre-Application (T0) Through 12 Hours Post Dosing (AUC [0-12 Hours])
timeFrame: 0 (predose) and 12 hours post dose on Day 0 (Baseline), Day 21
measure: Time at Which Maximum Concentration (Cmax) Occurred (Tmax)
timeFrame: Day 0 (Baseline), Day 21
Secondary outcomes:
measure: Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium, Urinary (U) Calcium Random) and Phosphorus Homeostasis up to Day 56
timeFrame: From baseline (Day 0) up to Day 56
measure: Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium Albumin Adjusted) Homeostasis up to Day 56
timeFrame: From baseline (Day 0) up to Day 56
measure: Change From Baseline in Effect of Calcitriol Ointment on Calcium (Urinary Calcium/Creatinine Ratio) Homeostasis up to Day 56
timeFrame: From baseline (Day 0) up to Day 56
measure: Number of Participants With Adverse Events
timeFrame: From start of the study to Day 56
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Dermatology Research of Arkansas
state: Arkansas
city: San Diego
country: United States
facility: Children's Hospital, Department of Pediatric and Adolescent Dermatology
state: California
city: Eagan
country: United States
facility: Dermatology Center For Children & Young Adults
state: Minnesota
city: Houston
country: United States
facility: University of Texas-Houston Medical Center Dept of Dermatology
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: St. John's
country: Canada
facility: Nexus Clinical Research
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Newlab Clinical Research, Inc.
state: Newfoundland and Labrador
Study officials:
affiliation: Galderma R&D
name: Michael Graeber, MD
role: STUDY_DIRECTOR
References: