Back to resultsA Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis
Primary Purpose
Chronic Plaque Psoriasis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Calcitriol 3mcg/g
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Plaque Psoriasis focused on measuring Calcitriol, Psoriasis, PK, Adolescents
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of chronic plaque psoriasis
- 10 - 35% BSA of involved skin
- Age 12 - 17
Exclusion Criteria:
- Other type of psoriasis (other than plaque)
- Significant abnormal lab findings
- Vit D insufficiency
Sites / Locations
- Dermatology Research of Arkansas
- Children's Hospital, Department of Pediatric and Adolescent Dermatology
- Dermatology Center For Children & Young Adults
- University of Texas-Houston Medical Center Dept of Dermatology
- Center for Clinical Studies
- Nexus Clinical Research
- Newlab Clinical Research, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Calcitriol 3mcg/g
Arm Description
Participants receive calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
Outcomes
Primary Outcome Measures
Trough Plasma Levels (Ctrough) of Calcitriol
Trough plasma levels (Ctrough) of calcitriol was reported.
The Observed Peak Drug Concentration (Cmax) of Calcitriol
Cmax of calcitriol was reported.
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.
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.
Time at Which Maximum Concentration (Cmax) Occurred (Tmax)
Tmax is the time to reach maximum concentration and was reported for calcitriol.
Secondary Outcome Measures
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium, Urinary (U) Calcium Random) and Phosphorus Homeostasis up to Day 56
Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Phosphorus homeostasis was analyzed with phosphorus as parameter. Change from baseline in the effect of calcitriol ointment on calcium (serum calcium, U calcium random) and phosphorus homeostasis up to Day 56 was reported.
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium Albumin Adjusted) Homeostasis up to Day 56
Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Change from baseline in the effect of calcitriol ointment on calcium (serum calcium albumin adjusted) homeostasis up to Day 56 was reported.
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Urinary Calcium/Creatinine Ratio) Homeostasis up to Day 56
Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Change from baseline in the effect of calcitriol ointment on calcium (urinary calcium/creatinine ratio) homeostasis up to Day 56 was reported.
Number of Participants With Adverse Events
An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding assessed as clinically significant and different from the baseline visit), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Number of participants with adverse events were reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00419666
Brief Title
A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis
Official Title
PK and PD of Calcitriol Following Twice Daily Application of Calcitriol 3 µg/g Ointment Under Conditions of Maximal Use in Adolescents With Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2006 (Actual)
Primary Completion Date
September 24, 2009 (Actual)
Study Completion Date
September 24, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque Psoriasis
Keywords
Calcitriol, Psoriasis, PK, Adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calcitriol 3mcg/g
Arm Type
Experimental
Arm Description
Participants receive calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
Intervention Type
Drug
Intervention Name(s)
Calcitriol 3mcg/g
Other Intervention Name(s)
CD2027, Vectical
Intervention Description
Calcitriol 3mcg/g ointment applied twice daily for 56 weeks.
Primary Outcome Measure Information:
Title
Trough Plasma Levels (Ctrough) of Calcitriol
Description
Trough plasma levels (Ctrough) of calcitriol was reported.
Time Frame
Day 0 (Baseline), Day 14, Day 21, and Day 56
Title
The Observed Peak Drug Concentration (Cmax) of Calcitriol
Description
Cmax of calcitriol was reported.
Time Frame
Day 0 (Baseline), Day 21
Title
Area Under the Concentration-Time Curve From Pre-Application (T0) Through 9 Hours Post Dosing (AUC [0-9 Hours])
Description
The AUC(0-9 hours) that is area under the plasma concentration-time curve from time 0 to 9 hours after dosing was reported.
Time Frame
0 (predose) and 9 hours post dose on Day 0 (Baseline), Day 21
Title
Area Under the Concentration-Time Curve From Pre-Application (T0) Through 12 Hours Post Dosing (AUC [0-12 Hours])
Description
The AUC(0-12 hours) that is area under the plasma concentration-time curve from time 0 to 12 hours after dosing was reported.
Time Frame
0 (predose) and 12 hours post dose on Day 0 (Baseline), Day 21
Title
Time at Which Maximum Concentration (Cmax) Occurred (Tmax)
Description
Tmax is the time to reach maximum concentration and was reported for calcitriol.
Time Frame
Day 0 (Baseline), Day 21
Secondary Outcome Measure Information:
Title
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium, Urinary (U) Calcium Random) and Phosphorus Homeostasis up to Day 56
Description
Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Phosphorus homeostasis was analyzed with phosphorus as parameter. Change from baseline in the effect of calcitriol ointment on calcium (serum calcium, U calcium random) and phosphorus homeostasis up to Day 56 was reported.
Time Frame
From baseline (Day 0) up to Day 56
Title
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium Albumin Adjusted) Homeostasis up to Day 56
Description
Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Change from baseline in the effect of calcitriol ointment on calcium (serum calcium albumin adjusted) homeostasis up to Day 56 was reported.
Time Frame
From baseline (Day 0) up to Day 56
Title
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Urinary Calcium/Creatinine Ratio) Homeostasis up to Day 56
Description
Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Change from baseline in the effect of calcitriol ointment on calcium (urinary calcium/creatinine ratio) homeostasis up to Day 56 was reported.
Time Frame
From baseline (Day 0) up to Day 56
Title
Number of Participants With Adverse Events
Description
An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding assessed as clinically significant and different from the baseline visit), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Number of participants with adverse events were reported.
Time Frame
From start of the study to Day 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of chronic plaque psoriasis
10 - 35% BSA of involved skin
Age 12 - 17
Exclusion Criteria:
Other type of psoriasis (other than plaque)
Significant abnormal lab findings
Vit D insufficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Graeber, MD
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
Dermatology Research of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Children's Hospital, Department of Pediatric and Adolescent Dermatology
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Dermatology Center For Children & Young Adults
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Facility Name
University of Texas-Houston Medical Center Dept of Dermatology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Center for Clinical Studies
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Nexus Clinical Research
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3E1
Country
Canada
Facility Name
Newlab Clinical Research, Inc.
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1C 2H5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis
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