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PK and PD Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Calcitriol 3 mcg/g ointment
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female pediatric subjects, 2 to 12 years of age inclusive at screening
  • Clinical diagnosis of plaque type psoriasis involving 3% through 35% body surface area at screening and baseline (excluding face and scalp)

Exclusion Criteria:

  • Subjects with guttate or pustular psoriasis, erythrodermic psoriasis or active infection
  • Vitamin D deficiency at screening
  • Subjects with hypercalcemia and out of range urinary calcium/creatinine ratio at screening
  • Subjects with secondary hyperparathyroidism at screening

Sites / Locations

  • Rady Children's Hospital - Pediatric and Adolescent Dermatology
  • Dawes Fretzin Clinical Research Group, LLC
  • University of Michigan Medical Center
  • University of North Carolina Dermatology and Skin Cancer Center
  • Cincinnati Children's Hospital Medical Center
  • Menter Dermatology Research Institute
  • Clinical Trials of Texas, Inc.
  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Calcitriol 3 mcg/g ointment

Arm Description

Topical application every 12 hours for 14 consecutive days

Outcomes

Primary Outcome Measures

Cmax of Calcitriol Plasma Level
Cmax of calcitriol plasma level at Day 14 (Peak plasma concentration of calcitriol from Day 1 to Day 14)
Cmin of Calcitriol Plasma Level
Cmin of calcitriol plasma level at Day 14
Tmax of Calcitriol Plasma Level
Tmax of calcitriol plasma level at Day 14
AUC (0-6h) of Calcitriol Plasma Level
AUC (0-6h) of calcitriol plasma level at Day 14 (Pre-dose to 6 hours post-dose)
AUC (0-9h) of Calcitriol Plasma Level
AUC (0-9h) of calcitriol plasma level at Day 14 (Pre-dose to 9 hours post-dose. For subjects with a body weight of <15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post-dose PK samples.)
AUC (0-12h) of Calcitriol Plasma Level
AUC (0-12h) of calcitriol plasma level at Day 14 (For subjects with a body weight of < 15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post dose PK samples. For subjects with a body weight of ≥ 15 kg, AUC (0-12h) was extrapolated based on the pre-dose to 9 hours post-dose PK samples.)

Secondary Outcome Measures

Full Information

First Posted
January 9, 2013
Last Updated
February 16, 2021
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT01766440
Brief Title
PK and PD Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
Official Title
Pharmacokinetics and Pharmacodynamics of Calcitriol 3 mcg/g Ointment Applied Twice Daily for 14 Days Under Conditions of Maximal Use in Pediatric Subjects (2 to 12 Years of Age) With Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if the calcitriol absorption in pediatric subjects is comparable to that in adults and adolescents, with no significant impact on calcium/phosphorus metabolism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calcitriol 3 mcg/g ointment
Arm Type
Experimental
Arm Description
Topical application every 12 hours for 14 consecutive days
Intervention Type
Drug
Intervention Name(s)
Calcitriol 3 mcg/g ointment
Intervention Description
Topical ointment; twice daily application
Primary Outcome Measure Information:
Title
Cmax of Calcitriol Plasma Level
Description
Cmax of calcitriol plasma level at Day 14 (Peak plasma concentration of calcitriol from Day 1 to Day 14)
Time Frame
Day 14
Title
Cmin of Calcitriol Plasma Level
Description
Cmin of calcitriol plasma level at Day 14
Time Frame
Day 14
Title
Tmax of Calcitriol Plasma Level
Description
Tmax of calcitriol plasma level at Day 14
Time Frame
Day 14
Title
AUC (0-6h) of Calcitriol Plasma Level
Description
AUC (0-6h) of calcitriol plasma level at Day 14 (Pre-dose to 6 hours post-dose)
Time Frame
Day 14
Title
AUC (0-9h) of Calcitriol Plasma Level
Description
AUC (0-9h) of calcitriol plasma level at Day 14 (Pre-dose to 9 hours post-dose. For subjects with a body weight of <15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post-dose PK samples.)
Time Frame
Day 14
Title
AUC (0-12h) of Calcitriol Plasma Level
Description
AUC (0-12h) of calcitriol plasma level at Day 14 (For subjects with a body weight of < 15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post dose PK samples. For subjects with a body weight of ≥ 15 kg, AUC (0-12h) was extrapolated based on the pre-dose to 9 hours post-dose PK samples.)
Time Frame
Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female pediatric subjects, 2 to 12 years of age inclusive at screening Clinical diagnosis of plaque type psoriasis involving 3% through 35% body surface area at screening and baseline (excluding face and scalp) Exclusion Criteria: Subjects with guttate or pustular psoriasis, erythrodermic psoriasis or active infection Vitamin D deficiency at screening Subjects with hypercalcemia and out of range urinary calcium/creatinine ratio at screening Subjects with secondary hyperparathyroidism at screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Graeber, M.D.
Organizational Affiliation
Galderma R&D, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Rady Children's Hospital - Pediatric and Adolescent Dermatology
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of North Carolina Dermatology and Skin Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Menter Dermatology Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

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PK and PD Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis

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