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Clinical Trials/NCT02125279
NCT02125279
Completed
Phase 4

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

Galderma R&D16 sites in 5 countries54 target enrollmentMay 2014
InterventionsCalcitriol

Overview

Phase
Phase 4
Intervention
Calcitriol
Conditions
Psoriasis Vulgaris
Sponsor
Galderma R&D
Enrollment
54
Locations
16
Primary Endpoint
Change From Screening in Serum Albumin Levels at Week 4
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
May 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Calcitriol ointment

Intervention: Calcitriol

Outcomes

Primary Outcomes

Change From Screening in Serum Albumin Levels at Week 4

Time Frame: Screening, Week 4

Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 4 were reported.

Change From Screening in Serum Albumin Levels at Week 12

Time Frame: Screening, Week 12

Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 12 were reported.

Change From Screening in Serum Albumin Levels at Week 26

Time Frame: Screening, Week 26

Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 26 were reported.

Change From Screening in Serum Albumin Levels at Week 30 (Follow-up)

Time Frame: Screening, 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.

Change From Screening in Urine Calcium/Creatinine Ratio at Week 30 (Follow-up)

Time Frame: Screening, 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.

Change From Screening in Serum Albumin Levels at Week 8

Time Frame: Screening, Week 8

Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 8 were reported.

Change From Screening in Urine Calcium/Creatinine Ratio at Week 26

Time Frame: Screening, 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.

Change From Screening in Serum Albumin Levels at Week 20

Time Frame: Screening, Week 20

Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 20 were reported.

Change From Screening in Serum Phosphate Levels at Week 12

Time Frame: Screening, Week 12

Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 12 were reported.

Change From Screening in Serum Parathyroid Hormone Levels at Week 26

Time Frame: Screening, Week 26

Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 26 were reported.

Change From Screening in Serum Phosphate Levels at Week 4

Time Frame: Screening, Week 4

Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 4 were reported.

Change From Screening in Serum Phosphate Levels at Week 20

Time Frame: Screening, Week 20

Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 20 were reported.

Change From Screening in Serum Phosphate Levels at Week 26

Time Frame: Screening, Week 26

Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 26 were reported.

Change From Screening in Serum Phosphate Levels at Week 30 (Follow-up)

Time Frame: Screening, 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.

Change From Screening in Serum Parathyroid Hormone Levels at Week 8

Time Frame: Screening, Week 8

Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 8 were reported.

Change From Screening in Serum Parathyroid Hormone Levels at Week 12

Time Frame: Screening, Week 12

Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 12 were reported.

Change From Screening in Urine Calcium/Creatinine Ratio at Week 12

Time Frame: Screening, 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.

Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 4

Time Frame: Screening, Week 4

Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 4 were reported.

Change From Screening in Serum Parathyroid Hormone Levels at Week 20

Time Frame: Screening, Week 20

Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 20 were reported.

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time Frame: Up to Week 30

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.

Change From Screening in Serum Parathyroid Hormone Levels at Week 30 (Follow-up)

Time Frame: Screening, 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.

Secondary Outcomes

  • Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit(Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up))
  • Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit(Weeks 4, 8, 12, 20, 26 and 30 (Follow-up))
  • Change From Baseline in Pruritus Score at Each Visit(Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up))

Study Sites (16)

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