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
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.
Investigators
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))