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

Chronic Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419666
• Other study ID #: RD.06.SPR.18102
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2006
• Est. completion date: September 24, 2009

Study information

• Verified date: November 2019
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 24, 2009
• Est. primary completion date: September 24, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Calcitriol 3mcg/g
Calcitriol 3mcg/g ointment applied twice daily for 56 weeks.

Locations

Country	Name	City	State
Canada	Newlab Clinical Research, Inc.	St. John's	Newfoundland and Labrador
Canada	Nexus Clinical Research	St. John's	Newfoundland and Labrador
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	Dermatology Research of Arkansas	Little Rock	Arkansas
United States	Children's Hospital, Department of Pediatric and Adolescent Dermatology	San Diego	California
United States	Center for Clinical Studies	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough Plasma Levels (Ctrough) of Calcitriol	Trough plasma levels (Ctrough) of calcitriol was reported.	Day 0 (Baseline), Day 14, Day 21, and Day 56
Primary	The Observed Peak Drug Concentration (Cmax) of Calcitriol	Cmax of calcitriol was reported.	Day 0 (Baseline), Day 21
Primary	Area Under the Concentration-Time Curve From Pre-Application (T0) Through 9 Hours Post Dosing (AUC [0-9 Hours])	The AUC(0-9 hours) that is area under the plasma concentration-time curve from time 0 to 9 hours after dosing was reported.	0 (predose) and 9 hours post dose on Day 0 (Baseline), Day 21
Primary	Area Under the Concentration-Time Curve From Pre-Application (T0) Through 12 Hours Post Dosing (AUC [0-12 Hours])	The AUC(0-12 hours) that is area under the plasma concentration-time curve from time 0 to 12 hours after dosing was reported.	0 (predose) and 12 hours post dose on Day 0 (Baseline), Day 21
Primary	Time at Which Maximum Concentration (Cmax) Occurred (Tmax)	Tmax is the time to reach maximum concentration and was reported for calcitriol.	Day 0 (Baseline), Day 21
Secondary	Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium, Urinary (U) Calcium Random) and Phosphorus Homeostasis 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.	From baseline (Day 0) up to Day 56
Secondary	Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium Albumin Adjusted) Homeostasis 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.	From baseline (Day 0) up to Day 56
Secondary	Change From Baseline in Effect of Calcitriol Ointment on Calcium (Urinary Calcium/Creatinine Ratio) Homeostasis 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.	From baseline (Day 0) up to Day 56
Secondary	Number of Participants With Adverse Events	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.	From start of the study to Day 56