Evaluate the Safety and Tolerability of Calcipotriene Foam, 0.005%, in Pediatric Subjects (Ages 2 to 11 Years, Inclusive) With Mild to Moderate Plaque Psoriasis.
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Multicenter, Open-label, Phase 1 Study of the Safety, Tolerability, Systemic Exposure, Pharmacodynamics, and Treatment Effect of Calcipotriene Foam, 0.005%, in Pediatric Subjects (Ages 2 to 11 Years) With Plaque Psoriasis|
- Describe the plasma concentrations (trough) of calcipotriene following administration of foam, 0.005%, in pediatric subjects (ages 2 to 11 years, inclusive) with moderate plaque psoriasis [ Time Frame: 8 weeks ]
- To evaluate the pharmacodynamic effect (ie, calcium metabolism) of calcipotriene foam 0.005%, in pediatric subjects (ages 2 to 11 years, inclusive) with mild to moderate plaque psoriasis. [ Time Frame: 2 weeks ]
- Tabulation of Concomitant Medications [ Time Frame: 8 weeks ]
- Extent of Calcipotriene exposure determined by amount of product used [ Time Frame: 8 weeks ]
- Compliance with Study Medication Assessment [ Time Frame: 8 weeks ]
- Adverse Event tabulation by severity, intensity, serious/non-serious, and treatment-emergent/non-TEAE [ Time Frame: 8 weeks ]
- Vital Sign tabulations [ Time Frame: 8 weeks ]averages across patients, visits, significant changes
- Clinical Laboratory Evaluations [ Time Frame: 8 weeks ]Shifts in lab parameters during treatment, clinically significant parameters
- Investigator Assessment of Tolerability - Erythema [ Time Frame: 8 weeks ]Change in assessment from baseline to EOT
- Subject Assessment of Tolerability- Pain [ Time Frame: 8 weeks ]Change in assessment from baseline to EOT
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||April 2019|
|Estimated Primary Completion Date:||April 2019 (Final data collection date for primary outcome measure)|
Experimental: Calcipotriene Foam
Foam is a vitamin D3 analog (calcipotriene) foam 0.005%. It is applied twice a day for 8 weeks to psoriasis lesions (except the face).
Drug: Calcipotriene 0.005% Foam
All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face).
Other Name: Sorilux
This is a multicenter, open-label, Phase 1 study in a total of 75 pediatric subjects, ages 2 to 11 years, inclusive, with mild or moderate plaque psoriasis.
The study will enroll sufficient subjects with plaque psoriasis and an ISGA score of mild to moderate (score of 2 or 3) at Baseline to ensure 50 evaluable subjects in a general use cohort.
In addition, a sufficient number of subjects with moderate plaque psoriasis will be enrolled to ensure 25 evaluable subjects in a 'maximum-use' cohort that have:
A. At least 10% total BSA with some scalp involvement (15 evaluable subjects ages 7 to 11 years) or B. At least 3% total BSA with some scalp involvement (10 evaluable subjects ages 2 to 6 years). "Napkin" psoriasis (psoriasis in the diaper area) can be included in the BSA calculation for this age group.
Subjects or their caregivers will apply a thin layer of study product twice a day to the treatment areas for 8 weeks. Any new psoriatic lesions appearing in treatment areas during the treatment period should also be treated with study product. Safety assessments (adverse event and serious adverse event query) will occur at all study visits. Treatment effect assessments, urine calcium metabolism assessments, and application site tolerability assessments will be performed for all subjects at all in-clinic visits. A blood sample will be taken from all subjects at Screening for evaluation of pharmacodynamic (PD) and 2,5-OH vitamin D levels, an additional blood draw for PD parameters will be taken at Week 2 for the maximum-use cohort only. Blood sampling for pharmacokinetic (PK) measurements will be performed in the maximum-use cohort at Screening and Week 2.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582932
|Contact: Karthi K Natarajan, MPHemail@example.com|
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