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

NCT00419666 | Completed Phase 2 Results

• 1 other identifier: RD.06.SPR.18102
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 7

Brief Summary

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.

Conditions

Chronic Plaque Psoriasis

Keywords

Calcitriol; Psoriasis; PK; Adolescents

Outcome Measures

Primary Outcomes (5)

• Trough Plasma Levels (Ctrough) of Calcitriol

  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

  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])

  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])

  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)

  Tmax is the time to reach maximum concentration and was reported for calcitriol.

  Day 0 (Baseline), Day 21

Secondary Outcomes (4)

• Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium, Urinary (U) Calcium Random) and Phosphorus Homeostasis up to Day 56

  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

  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

  From baseline (Day 0) up to Day 56

• Number of Participants With Adverse Events

  From start of the study to Day 56

Study Arms (1)

Calcitriol 3mcg/g

EXPERIMENTAL

Participants receive calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.

Drug: Calcitriol 3mcg/g

Interventions

Calcitriol 3mcg/g DRUG

Calcitriol 3mcg/g ointment applied twice daily for 56 weeks.

Also known as: CD2027, Vectical

Calcitriol 3mcg/g

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of chronic plaque psoriasis
• % BSA of involved skin
• Age 12 - 17

You may not qualify if:

• Other type of psoriasis (other than plaque)
• Significant abnormal lab findings
• Vit D insufficiency

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (7)

Dermatology Research of Arkansas

Little Rock, Arkansas, 72205, United States

Location

Children's Hospital, Department of Pediatric and Adolescent Dermatology

San Diego, California, 92123, United States

Location

Dermatology Center For Children & Young Adults

Eagan, Minnesota, 55121, United States

Location

University of Texas-Houston Medical Center Dept of Dermatology

Houston, Texas, 77030, United States

Location

Center for Clinical Studies

Webster, Texas, 77598, United States

Location

Nexus Clinical Research

St. John's, Newfoundland and Labrador, A1B 3E1, Canada

Location

Newlab Clinical Research, Inc.

St. John's, Newfoundland and Labrador, A1C 2H5, Canada

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Study Officials

• Michael Graeber, MD

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2007
• First Posted: January 9, 2007
• Study Start: August 1, 2006
• Primary Completion: September 24, 2009
• Study Completion: September 24, 2009
• Last Updated: February 18, 2021
• Results First Posted: December 10, 2019

Record last verified: 2019-11

Locations

CA (2); US (5)