A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis
- Registration Number
- NCT00419666
- Lead Sponsor
- Galderma R&D
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- Diagnosis of chronic plaque psoriasis
- 10 - 35% BSA of involved skin
- Age 12 - 17
- Other type of psoriasis (other than plaque)
- Significant abnormal lab findings
- Vit D insufficiency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Calcitriol 3mcg/g Calcitriol 3mcg/g Participants receive calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
- Primary Outcome Measures
Name Time Method Trough Plasma Levels (Ctrough) of Calcitriol Day 0 (Baseline), Day 14, Day 21, and Day 56 Trough plasma levels (Ctrough) of calcitriol was reported.
Area Under the Concentration-Time Curve From Pre-Application (T0) Through 12 Hours Post Dosing (AUC [0-12 Hours]) 0 (predose) and 12 hours post dose on Day 0 (Baseline), Day 21 The AUC(0-12 hours) that is area under the plasma concentration-time curve from time 0 to 12 hours after dosing was reported.
The Observed Peak Drug Concentration (Cmax) of Calcitriol Day 0 (Baseline), Day 21 Cmax of calcitriol was reported.
Area Under the Concentration-Time Curve From Pre-Application (T0) Through 9 Hours Post Dosing (AUC [0-9 Hours]) 0 (predose) and 9 hours post dose on Day 0 (Baseline), Day 21 The AUC(0-9 hours) that is area under the plasma concentration-time curve from time 0 to 9 hours after dosing was reported.
Time at Which Maximum Concentration (Cmax) Occurred (Tmax) Day 0 (Baseline), Day 21 Tmax is the time to reach maximum concentration and was reported for calcitriol.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium, Urinary (U) Calcium Random) and Phosphorus Homeostasis up to Day 56 From baseline (Day 0) up to Day 56 Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Phosphorus homeostasis was analyzed with phosphorus as parameter. Change from baseline in the effect of calcitriol ointment on calcium (serum calcium, U calcium random) and phosphorus homeostasis up to Day 56 was reported.
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium Albumin Adjusted) Homeostasis up to Day 56 From baseline (Day 0) up to Day 56 Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Change from baseline in the effect of calcitriol ointment on calcium (serum calcium albumin adjusted) homeostasis up to Day 56 was reported.
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Urinary Calcium/Creatinine Ratio) Homeostasis up to Day 56 From baseline (Day 0) up to Day 56 Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Change from baseline in the effect of calcitriol ointment on calcium (urinary calcium/creatinine ratio) homeostasis up to Day 56 was reported.
Number of Participants With Adverse Events From start of the study to Day 56 An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding assessed as clinically significant and different from the baseline visit), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Number of participants with adverse events were reported.
Trial Locations
- Locations (7)
Children's Hospital, Department of Pediatric and Adolescent Dermatology
🇺🇸San Diego, California, United States
Center for Clinical Studies
🇺🇸Webster, Texas, United States
Dermatology Center For Children & Young Adults
🇺🇸Eagan, Minnesota, United States
Dermatology Research of Arkansas
🇺🇸Little Rock, Arkansas, United States
University of Texas-Houston Medical Center Dept of Dermatology
🇺🇸Houston, Texas, United States
Newlab Clinical Research, Inc.
🇨🇦St. John's, Newfoundland and Labrador, Canada
Nexus Clinical Research
🇨🇦St. John's, Newfoundland and Labrador, Canada