Phase 2
N=25
A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis
Chronic Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT00419666 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Trough Plasma Levels (Ctrough) of Calcitriol — 65.04; 62.53; 61.87; 61.46 Picograms Per Millilitre (pg/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Calcitriol 3mcg/g (Drug)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Plasma Levels (Ctrough) of Calcitriol |
65.04; 62.53; 61.87; 61.46 | — |
| PRIMARY The Observed Peak Drug Concentration (Cmax) of Calcitriol |
75.74; 73.18 | — |
| PRIMARY Area Under the Concentration-Time Curve From Pre-Application (T0) Through 9 Hours Post Dosing (AUC [0-9 Hours]) |
575.12; 549.29 | — |
| PRIMARY Area Under the Concentration-Time Curve From Pre-Application (T0) Through 12 Hours Post Dosing (AUC [0-12 Hours]) |
764.74; 737.74 | — |
| PRIMARY Time at Which Maximum Concentration (Cmax) Occurred (Tmax) |
4.00; 3.97 | — |
| SECONDARY Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium, Urinary (U) Calcium Random) and Phosphorus Homeostasis up to Day 56 |
0.08; 1.00; 0.20 | — |
| SECONDARY Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium Albumin Adjusted) Homeostasis up to Day 56 |
-0.01 | — |
| SECONDARY Change From Baseline in Effect of Calcitriol Ointment on Calcium (Urinary Calcium/Creatinine Ratio) Homeostasis up to Day 56 |
0.01 | — |
| SECONDARY Number of Participants With Adverse Events |
13 | — |
Summary
This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied twice daily to involved skin (10 - 35% BSA involved, excluding face, scalp and intertriginous areas) for 56 days (8 weeks). Full Pharmacokinetic (PK) and Pharmacodynamic (PD) profile will be collected during the first 3 weeks of the study; safety and efficacy data will be collected for the 8 weeks of the treatment.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of chronic plaque psoriasis
- 10 - 35% BSA of involved skin
- Age 12 - 17
Exclusion Criteria
- Other type of psoriasis (other than plaque)
- Significant abnormal lab findings
- Vit D insufficiency
Data sourced from ClinicalTrials.gov (NCT00419666). 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.