NCT01766440

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2013

Typical duration for phase_4

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 31, 2017

Completed
Last Updated

February 18, 2021

Status Verified

April 1, 2017

Enrollment Period

2.7 years

First QC Date

January 9, 2013

Results QC Date

February 15, 2017

Last Update Submit

February 16, 2021

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (6)

  • Cmax of Calcitriol Plasma Level

    Cmax of calcitriol plasma level at Day 14 (Peak plasma concentration of calcitriol from Day 1 to Day 14)

    Day 14

  • Cmin of Calcitriol Plasma Level

    Cmin of calcitriol plasma level at Day 14

    Day 14

  • Tmax of Calcitriol Plasma Level

    Tmax of calcitriol plasma level at Day 14

    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)

    Day 14

  • 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.)

    Day 14

  • 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.)

    Day 14

Study Arms (1)

Calcitriol 3 mcg/g ointment

EXPERIMENTAL

Topical application every 12 hours for 14 consecutive days

Drug: Calcitriol 3 mcg/g ointment

Interventions

Calcitriol 3 mcg/g ointmentDRUG

Topical ointment; twice daily application

Calcitriol 3 mcg/g ointment

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Rady Children's Hospital - Pediatric and Adolescent Dermatology

San Diego, California, 92123, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46256, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

University of North Carolina Dermatology and Skin Cancer Center

Chapel Hill, North Carolina, 27516, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Menter Dermatology Research Institute

Dallas, Texas, 75246, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Interventions

CalcitriolOintments

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsDosage FormsPharmaceutical Preparations

Limitations and Caveats

Study was terminated early due to slow enrollment.

Results Point of Contact

Title
Michael Graeber
Organization
Galderma
michael.graeber@galderma.com
(817)961-5000

Study Officials

  • Michael Graeber, M.D.

    Galderma R&D, LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2013

First Posted

January 11, 2013

Study Start

March 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

February 18, 2021

Results First Posted

March 31, 2017

Record last verified: 2017-04

Locations

US(8)