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Safety, Tolerability, PD & PK of Calcipotriene 0.005% Foam, Under Maximal Use in 12-16 Year Olds With Plaque Psoriasis


Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for the treatment of plaque psoriasis in adults aged 18 years and older. The current study is a multicenter study in which adolescent subjects (ages 12 to 16 years, inclusive) or their primary caregivers will apply calcipotriene foam, 0.005%, as a thin layer to treatment areas of the body and scalp, excluding the face, under maximal use conditions, twice a day for 14 days and once on Day 15. The safety, tolerability, pharmacodynamics, and pharmacokinetics of calcipotriene will be evaluated

Condition Intervention Phase
Psoriasis Drug: Calcipotriene 0.005% Foam Phase 1

Study Type: Interventional
Study Design:Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title:A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Calcipotriene Foam, 0.005%, Applied Under Maximal-Use Conditions in Adolescent Subjects (Ages 12 to 16 Years) With Plaque Psoriasis

Resource links provided by NLM:

Further study details as provided by Mayne Pharma International Pty Ltd:

Primary Outcome Measures:

  • Effect of calcium metabolism [ Time Frame: Up to 3 Weeks ]
    determine albumin-adjusted calcium, iPTH, alkaline phosphatase, and phosphorus

Secondary Outcome Measures:

  • Pharmacokinetics [ Time Frame: predose, 1,2,3,4,6 hours postdose ]
    Area Under Curve (AUC)

Estimated Enrollment:30
Study Start Date:April 2012
Estimated Study Completion Date:June 2017
Estimated Primary Completion Date:June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calcipotriene Foam

Calcipotriene foam 0.005% administered under maximal-use conditions to adolescent patients with plaque psoriasis
Drug: Calcipotriene 0.005% Foam

Topical application applied twice a day for 15 days
Other Name: Sorilux

Detailed Description:

This Phase 1 multicenter, open-label, repeat-dose study is designed to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of calcipotriene foam, 0.005%, applied topically to adolescent subjects with moderate plaque psoriasis (defined as a score of 3 on the Investigator’s Static Global Assessment [ISGA]) involving a minimum of 10% body surface area (BSA) excluding the face and scalp, and a minimum of 20% scalp involvement. Subjects will be enrolled no more than 2 weeks after Screening. Approximately 30 eligible subjects, ages 12 to 16 years, inclusive, will be enrolled to ensure 20 completing subjects. Calcipotriene foam will be applied as a thin layer twice a day for 14 days and once on Day 15 on all treatment areas. Blood samples for the evaluation of albumin adjusted calcium, intact parathyroid hormone (iPTH), alkaline phosphatase, magnesium, and phosphorus will be taken at Screening and on Day 1 (before the first dose), Day 15 (3 to 9 hours after dosing), and on Day 22 if the results from Day 15 show any abnormalities. Serum 25-OH vitamin D concentrations will be evaluated on Day 1 (before the first dose). Safety and tolerability will be evaluated throughout the treatment period and a 7 day follow-up period. Blood samples for pharmacokinetic (PK) evaluation will be collected on Days 1 and 15. Urine samples for evaluation of calcium/creatinine ratio will be collected before dosing on Days 1 and 15.


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