A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis

Study Overview
=================
Brief 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.

Official Title
-----------------
PK and PD of Calcitriol Following Twice Daily Application of Calcitriol 3 µg/g Ointment Under Conditions of Maximal Use in Adolescents With Plaque Psoriasis

Conditions
-----------------
Chronic Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: Calcitriol 3mcg/g


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcitriol 3mcg/g<br>Participants receive calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days. | Drug: Calcitriol 3mcg/g<br>* Calcitriol 3mcg/g ointment applied twice daily for 56 weeks.<br>* Other names: Vectical;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough Plasma Levels (Ctrough) of Calcitriol | Trough plasma levels (Ctrough) of calcitriol was reported. | Day 0 (Baseline), Day 14, Day 21, and Day 56 | 
| The Observed Peak Drug Concentration (Cmax) of Calcitriol | Cmax of calcitriol was reported. | Day 0 (Baseline), Day 21 | 
| Area Under the Concentration-Time Curve From Pre-Application (T0) Through 9 Hours Post Dosing (AUC [0-9 Hours]) | The AUC(0-9 hours) that is area under the plasma concentration-time curve from time 0 to 9 hours after dosing was reported. | 0 (predose) and 9 hours post dose on Day 0 (Baseline), Day 21 | 
| Area Under the Concentration-Time Curve From Pre-Application (T0) Through 12 Hours Post Dosing (AUC [0-12 Hours]) | The AUC(0-12 hours) that is area under the plasma concentration-time curve from time 0 to 12 hours after dosing was reported. | 0 (predose) and 12 hours post dose on Day 0 (Baseline), Day 21 | 
| Time at Which Maximum Concentration (Cmax) Occurred (Tmax) | Tmax is the time to reach maximum concentration and was reported for calcitriol. | Day 0 (Baseline), Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium, Urinary (U) Calcium Random) and Phosphorus Homeostasis up to Day 56 | Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Phosphorus homeostasis was analyzed with phosphorus as parameter. Change from baseline in the effect of calcitriol ointment on calcium (serum calcium, U calcium random) and phosphorus homeostasis up to Day 56 was reported. | From baseline (Day 0) up to Day 56 | 
| Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium Albumin Adjusted) Homeostasis up to Day 56 | Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Change from baseline in the effect of calcitriol ointment on calcium (serum calcium albumin adjusted) homeostasis up to Day 56 was reported. | From baseline (Day 0) up to Day 56 | 
| Change From Baseline in Effect of Calcitriol Ointment on Calcium (Urinary Calcium/Creatinine Ratio) Homeostasis up to Day 56 | Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Change from baseline in the effect of calcitriol ointment on calcium (urinary calcium/creatinine ratio) homeostasis up to Day 56 was reported. | From baseline (Day 0) up to Day 56 | 
| Number of Participants With Adverse Events | An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding assessed as clinically significant and different from the baseline visit), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Number of participants with adverse events were reported. | From start of the study to Day 56 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Calcitriol, Psoriasis, PK, Adolescents