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Completed

NCT Number: NCT01766440

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

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.

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Key information

Conditions

Plaque Psoriasis

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rady Children's Hospital - Pediatric and Adolescent Dermatology, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcitriol 3 mcg/g ointment

Drug

Topical ointment; twice daily application

Primary outcomes

  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.)

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 11, 2013
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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