Phase 4
Completed N=54
Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
Source: ClinicalTrials.gov NCT02125279 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Change From Screening in Serum Albumin Levels at Week 4 — -1.0 gram per liter (g/L)
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Screening in Serum Albumin Levels at Week 4 |
-1.0 | — |
| PRIMARY Change From Screening in Serum Albumin Levels at Week 8 |
-1.0 | — |
| PRIMARY Change From Screening in Serum Albumin Levels at Week 12 |
-0.8 | — |
| PRIMARY Change From Screening in Serum Albumin Levels at Week 20 |
-1.1 | — |
| PRIMARY Change From Screening in Serum Albumin Levels at Week 26 |
-0.8 | — |
| PRIMARY Change From Screening in Serum Albumin Levels at Week 30 (Follow-up) |
-0.2 | — |
| PRIMARY Change From Screening in Urine Calcium/Creatinine Ratio at Week 12 |
-0.0164 | — |
| PRIMARY Change From Screening in Urine Calcium/Creatinine Ratio at Week 26 |
0.0456 | — |
| PRIMARY Change From Screening in Urine Calcium/Creatinine Ratio at Week 30 (Follow-up) |
0.0715 | — |
| PRIMARY Change From Screening in Serum Phosphate Levels at Week 4 |
0.0334 | — |
| PRIMARY Change From Screening in Serum Phosphate Levels at Week 12 |
0.0237 | — |
| PRIMARY Change From Screening in Serum Phosphate Levels at Week 20 |
0.0079 | — |
| PRIMARY Change From Screening in Serum Phosphate Levels at Week 26 |
0.0091 | — |
| PRIMARY Change From Screening in Serum Phosphate Levels at Week 30 (Follow-up) |
0.0145 | — |
| PRIMARY Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 4 |
0.14 | — |
| PRIMARY Change From Screening in Serum Parathyroid Hormone Levels at Week 8 |
0.09 | — |
| PRIMARY Change From Screening in Serum Parathyroid Hormone Levels at Week 12 |
0.04 | — |
| PRIMARY Change From Screening in Serum Parathyroid Hormone Levels at Week 20 |
0.17 | — |
| PRIMARY Change From Screening in Serum Parathyroid Hormone Levels at Week 26 |
-0.07 | — |
| PRIMARY Change From Screening in Serum Parathyroid Hormone Levels at Week 30 (Follow-up) |
0.37 | — |
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
20 | — |
| SECONDARY Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit |
3; 5; 15; 14; 19; 17 | — |
| SECONDARY Change From Baseline in Pruritus Score at Each Visit |
-0.6; -0.7; -0.7; -0.7; -0.9; -0.8 | — |
| SECONDARY Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit |
-1.3; -2.5; -3.4; -4.4; -3.9; -4.7 | — |
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
Data sourced from ClinicalTrials.gov (NCT02125279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.