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

February 16, 2021 updated by: Galderma R&D

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3E1
        • Nexus Clinical Research
      • St. John's, Newfoundland and Labrador, Canada, A1C 2H5
        • NewLab Clinical Research, Inc.
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Dermatology Research of Arkansas
    • California
      • San Diego, California, United States, 92123
        • Children's Hospital, Department of Pediatric and Adolescent Dermatology
    • Minnesota
      • Eagan, Minnesota, United States, 55121
        • Dermatology Center for Children & Young Adults
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas-Houston Medical Center Dept of Dermatology
      • Webster, Texas, United States, 77598
        • Center for Clinical Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calcitriol 3mcg/g
Participants receive calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
Drug: Calcitriol 3mcg/g
Calcitriol 3mcg/g ointment applied twice daily for 56 weeks.
Other Names:
  • CD2027
  • Vectical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Plasma Levels (Ctrough) of Calcitriol
Time Frame: Day 0 (Baseline), Day 14, Day 21, and Day 56
Trough plasma levels (Ctrough) of calcitriol was reported.
Day 0 (Baseline), Day 14, Day 21, and Day 56
The Observed Peak Drug Concentration (Cmax) of Calcitriol
Time Frame: Day 0 (Baseline), Day 21
Cmax of calcitriol was reported.
Day 0 (Baseline), Day 21
Area Under the Concentration-Time Curve From Pre-Application (T0) Through 9 Hours Post Dosing (AUC [0-9 Hours])
Time Frame: 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.
0 (predose) and 9 hours post dose on Day 0 (Baseline), Day 21
Area Under the Concentration-Time Curve From Pre-Application (T0) Through 12 Hours Post Dosing (AUC [0-12 Hours])
Time Frame: 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.
0 (predose) and 12 hours post dose on Day 0 (Baseline), Day 21
Time at Which Maximum Concentration (Cmax) Occurred (Tmax)
Time Frame: Day 0 (Baseline), Day 21
Tmax is the time to reach maximum concentration and was reported for calcitriol.
Day 0 (Baseline), Day 21

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium, Urinary (U) Calcium Random) and Phosphorus Homeostasis up to Day 56
Time Frame: 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.
From baseline (Day 0) up to Day 56
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium Albumin Adjusted) Homeostasis up to Day 56
Time Frame: 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.
From baseline (Day 0) up to Day 56
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Urinary Calcium/Creatinine Ratio) Homeostasis up to Day 56
Time Frame: 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.
From baseline (Day 0) up to Day 56
Number of Participants With Adverse Events
Time Frame: 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.
From start of the study to Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2006

Primary Completion (Actual)

September 24, 2009

Study Completion (Actual)

September 24, 2009

Study Registration Dates

First Submitted

January 5, 2007

First Submitted That Met QC Criteria

January 5, 2007

First Posted (Estimate)

January 9, 2007

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.06.SPR.18102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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