Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: Calcitriol

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • UZ Gent Dermatology Department
• Canada
  • Ontario
    • Markham, Ontario, Canada, L3P1X2
      • Lynderm Research Inc.
  • Quebec
    • Montreal, Quebec, Canada, H3T1C5
      • CHU Sainte-Justine
• Germany
  • Berlin, Germany, 10117
    • Charité Universitätsmedizin Berlin
  • Dresden, Germany, 01307
    • University Hospital Carl Gustav Carus
  • Mainz, Germany, 55131
    • Universitäts-Hautklinik Mainz, Johannes Gutenberg-Universität Mainz
• Italy
  • Padova, Italy, 35128
    • Padova University Hospital
  • Parma, Italy, 43126
    • University of Parma
• United States
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Johnson Dermatology
    • Rogers, Arkansas, United States, 72758
      • Northwest Arkansas Clinical Trials Center, PLLC
  • California
    • Burbank, California, United States, 91505
      • Advanced Skincare Surgery & MedCenter
  • Florida
    • Tampa, Florida, United States, 33612
      • University of South Florida
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Shideler Clinical Research Center
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Clinical Research Group
  • New York
    • New York, New York, United States, 10467
      • Montefiore Medical Center
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center for Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Calcitriol ointment	Drug: Calcitriol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Screening in Serum Albumin Levels at Week 4	Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 4 were reported.	Screening, Week 4
Change From Screening in Serum Albumin Levels at Week 8	Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 8 were reported.	Screening, Week 8
Change From Screening in Serum Albumin Levels at Week 12	Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 12 were reported.	Screening, Week 12
Change From Screening in Serum Albumin Levels at Week 20	Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 20 were reported.	Screening, Week 20
Change From Screening in Serum Albumin Levels at Week 26	Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 26 were reported.	Screening, Week 26
Change From Screening in Serum Albumin Levels at Week 30 (Follow-up)	Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 30 were reported.	Screening, Week 30 (Follow-up)
Change From Screening in Urine Calcium/Creatinine Ratio at Week 12	Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 12 were reported.	Screening, Week 12
Change From Screening in Urine Calcium/Creatinine Ratio at Week 26	Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 26 were reported.	Screening, Week 26
Change From Screening in Urine Calcium/Creatinine Ratio at Week 30 (Follow-up)	Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 30 were reported.	Screening, Week 30 (Follow-up)
Change From Screening in Serum Phosphate Levels at Week 4	Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 4 were reported.	Screening, Week 4
Change From Screening in Serum Phosphate Levels at Week 12	Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 12 were reported.	Screening, Week 12
Change From Screening in Serum Phosphate Levels at Week 20	Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 20 were reported.	Screening, Week 20
Change From Screening in Serum Phosphate Levels at Week 26	Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 26 were reported.	Screening, Week 26
Change From Screening in Serum Phosphate Levels at Week 30 (Follow-up)	Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 30 were reported.	Screening, Week 30 (Follow-up)
Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 4	Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 4 were reported.	Screening, Week 4
Change From Screening in Serum Parathyroid Hormone Levels at Week 8	Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 8 were reported.	Screening, Week 8
Change From Screening in Serum Parathyroid Hormone Levels at Week 12	Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 12 were reported.	Screening, Week 12
Change From Screening in Serum Parathyroid Hormone Levels at Week 20	Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 20 were reported.	Screening, Week 20
Change From Screening in Serum Parathyroid Hormone Levels at Week 26	Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 26 were reported.	Screening, Week 26
Change From Screening in Serum Parathyroid Hormone Levels at Week 30 (Follow-up)	Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 30 were reported.	Screening, Week 30 (Follow-up)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with an onset date on or after the first application of the study drug.	Up to Week 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit	The IGA is a 0 to 4 point scale. Where, 0 = clear (no signs of psoriasis except for residual hypopigmentation/hyperpigmentation); 1 = almost clear (just perceptible erythema, no induration, and no scaling); 2 = mild (mild erythema, no induration, and mild or no scaling); 3 = moderate (moderate erythema, mild induration, and mild or no scaling); 4 = severe (severe erythema, moderate to severe induration, and scaling of any degree).	Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
Change From Baseline in Pruritus Score at Each Visit	Pruritus was scored on a 0 to 4 point scale. Where, 0 = none (no-itching); 1 = mild (slight itching, not really bothersome); 2 = moderate (definite itching that is somewhat bothersome without loss of sleep); 3 = severe (intense itching that has caused pronounced discomfort, night rest interrupted); 4 = very severe (very severe itching that has caused pronounced discomfort during the night and daily activities). Positive change from baseline indicate worsening of indication.	Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit	Percent BSA was calculated by modified rules of nines (pediatric participants). Estimate were made from the following for a child up to the age of one year: head and neck total for front and back - 18%; thorax and abdomen-front -18%; thorax and abdomen-back - 18%; each upper limb total for front and back - 9%; each lower limb total for front and back - 14%. For over the age of one year, the relative percentage of BSA changes as follows: the head decreases by 1% per year and the lower limbs increase by 0.5% per year. By the age of ten years, the relative proportions assume the values for adult BSA as follows: perineum becomes 1%; each lower limb becomes a total of 18% front and back; head and neck become 9% total for front and back.	Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Study Director: Michael Graeber, MD, Galderma R&D, LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: March 28, 2014
• First Submitted That Met QC Criteria: April 25, 2014
• First Posted (Estimate): April 29, 2014

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Micronutrients; Membrane Transport Modulators; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Calcitriol
• Other Study ID Numbers: RD.06.SPR.18131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No