Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Plaque Psoriasis

Keywords

CalcitriolPsoriasisPKAdolescents

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.

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/gDrug

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

Also known as: CD2027, Vectical

Calcitriol 3mcg/g

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age12 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Diagnosis of chronic plaque psoriasis
% BSA of involved skin

Sponsors & Collaborators

Galderma R&D
Industrylead

Study Sites (7)

Dermatology Research of Arkansas

Little Rock, Arkansas, 72205, United States

Children's Hospital, Department of Pediatric and Adolescent Dermatology

San Diego, California, 92123, United States

Dermatology Center For Children & Young Adults

Eagan, Minnesota, 55121, United States

University of Texas-Houston Medical Center Dept of Dermatology

Houston, Texas, 77030, United States

Center for Clinical Studies

Webster, Texas, 77598, United States

Nexus Clinical Research

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

Newlab Clinical Research, Inc.

MeSH Terms

Conditions

Psoriasis

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring Compounds

Results Point of Contact

Title: Clinical Operations
Organization: Galderma

Study Officials

Michael Graeber, MD
Galderma R&D
STUDY DIRECTOR

Publication Agreements

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

Enrollment

25 participants (actual enrollment reported by the registry).

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

Actual (reported)

Primary Completion

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (4)

Study Arms (1)

Calcitriol 3mcg/g

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (4)

Study Arms (1)

Calcitriol 3mcg/g

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations