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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01766440
Recruitment Status : Completed
First Posted : January 11, 2013
Results First Posted : March 31, 2017
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Study Description
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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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Calcitriol 3 mcg/g ointment Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Calcitriol

Arms and Interventions
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Arm Intervention/treatment
Experimental: Calcitriol 3 mcg/g ointment
Topical application every 12 hours for 14 consecutive days
 Drug: Calcitriol 3 mcg/g ointment
Topical ointment; twice daily application


Outcome Measures
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Primary Outcome Measures :
  1. Cmax of Calcitriol Plasma Level [ Time Frame: Day 14 ]
    Cmax of calcitriol plasma level at Day 14 (Peak plasma concentration of calcitriol from Day 1 to Day 14)

  2. Cmin of Calcitriol Plasma Level [ Time Frame: Day 14 ]
    Cmin of calcitriol plasma level at Day 14

  3. Tmax of Calcitriol Plasma Level [ Time Frame: Day 14 ]
    Tmax of calcitriol plasma level at Day 14

  4. AUC (0-6h) of Calcitriol Plasma Level [ Time Frame: Day 14 ]
    AUC (0-6h) of calcitriol plasma level at Day 14 (Pre-dose to 6 hours post-dose)

  5. AUC (0-9h) of Calcitriol Plasma Level [ Time Frame: Day 14 ]
    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.)

  6. AUC (0-12h) of Calcitriol Plasma Level [ Time Frame: Day 14 ]
    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.)


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766440


Locations
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United States, California
Rady Children's Hospital - Pediatric and Adolescent Dermatology
San Diego, California, United States, 92123
United States, Indiana
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46256
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
University of North Carolina Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, United States, 27516
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Texas
Menter Dermatology Research Institute
Dallas, Texas, United States, 75246
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Galderma R&D
Investigators
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Study Director: Michael Graeber, M.D. Galderma R&D, LLC
More Information
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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01766440    
Other Study ID Numbers: RD.06. SPR.18104
First Posted: January 11, 2013    Key Record Dates
Results First Posted: March 31, 2017
Last Update Posted: February 18, 2021
Last Verified: April 2017
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcitriol
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Bone Density Conservation Agents