Clinical trial NCT02125279: Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
Official title: A Multicenter Open Label Uncontrolled Study of the Long Term Safety and Efficacy of Calcitriol 3 mcg/g Ointment Applied Twice Daily for 26 Weeks in Pediatric Subjects (2 to 16 Years and 11 mo of Age) With Mild to Moderate Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis Vulgaris
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2014-04-29
Enrollment: 54
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and efficacy of up to 26 weeks of treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat pediatric subjects (2 to 16 years and 11 months of age) with mild to moderate plaque psoriasis.


Eligibility criteria: Inclusion Criteria:

* Male or female 2 to 16 years and 11 months of age
* Clinical diagnosis of stable mild to moderate plaque psoriasis

Exclusion Criteria:

* Other forms of psoriasis
* Hypercalcemia
* Past history of kidney stones
* Vitamin D deficiency
* Other concomitant dermatological disease

Primary outcomes:
measure: Change From Screening in Serum Albumin Levels at Week 4
timeFrame: Screening, Week 4
measure: Change From Screening in Serum Albumin Levels at Week 8
timeFrame: Screening, Week 8
measure: Change From Screening in Serum Albumin Levels at Week 12
timeFrame: Screening, Week 12
measure: Change From Screening in Serum Albumin Levels at Week 20
timeFrame: Screening, Week 20
measure: Change From Screening in Serum Albumin Levels at Week 26
timeFrame: Screening, Week 26
measure: Change From Screening in Serum Albumin Levels at Week 30 (Follow-up)
timeFrame: Screening, Week 30 (Follow-up)
measure: Change From Screening in Urine Calcium/Creatinine Ratio at Week 12
timeFrame: Screening, Week 12
measure: Change From Screening in Urine Calcium/Creatinine Ratio at Week 26
timeFrame: Screening, Week 26
measure: Change From Screening in Urine Calcium/Creatinine Ratio at Week 30 (Follow-up)
timeFrame: Screening, Week 30 (Follow-up)
measure: Change From Screening in Serum Phosphate Levels at Week 4
timeFrame: Screening, Week 4
measure: Change From Screening in Serum Phosphate Levels at Week 12
timeFrame: Screening, Week 12
measure: Change From Screening in Serum Phosphate Levels at Week 20
timeFrame: Screening, Week 20
measure: Change From Screening in Serum Phosphate Levels at Week 26
timeFrame: Screening, Week 26
measure: Change From Screening in Serum Phosphate Levels at Week 30 (Follow-up)
timeFrame: Screening, Week 30 (Follow-up)
measure: Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 4
timeFrame: Screening, Week 4
measure: Change From Screening in Serum Parathyroid Hormone Levels at Week 8
timeFrame: Screening, Week 8
measure: Change From Screening in Serum Parathyroid Hormone Levels at Week 12
timeFrame: Screening, Week 12
measure: Change From Screening in Serum Parathyroid Hormone Levels at Week 20
timeFrame: Screening, Week 20
measure: Change From Screening in Serum Parathyroid Hormone Levels at Week 26
timeFrame: Screening, Week 26
measure: Change From Screening in Serum Parathyroid Hormone Levels at Week 30 (Follow-up)
timeFrame: Screening, Week 30 (Follow-up)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to Week 30
Secondary outcomes:
measure: Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit
timeFrame: Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
measure: Change From Baseline in Pruritus Score at Each Visit
timeFrame: Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
measure: Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit
timeFrame: Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center, PLLC
state: Arkansas
city: Burbank
country: United States
facility: Advanced Skincare Surgery & Medcenter
state: California
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Carmel
country: United States
facility: Shideler Clinical Research Center
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group
state: Indiana
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
city: Arlington
country: United States
facility: Arlington Research Center for Dermatology
state: Texas
city: Gent
country: Belgium
facility: UZ Gent Dermatology Department
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus
city: Mainz
country: Germany
facility: Universitäts-Hautklinik Mainz, Johannes Gutenberg-Universität Mainz
city: Padova
country: Italy
facility: Padova University Hospital
city: Parma
country: Italy
facility: University of Parma
Study officials:
affiliation: Galderma R&D, LLC
name: Michael Graeber, MD
role: STUDY_DIRECTOR
References: