Evaluate Safety and Tolerability of Calcipotriene Foam 0.005% in Pediatric Subjects With Mild/Moderate Plaque Psoriasis
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|ClinicalTrials.gov Identifier: NCT01582932|
Recruitment Status : Completed
First Posted : April 23, 2012
Last Update Posted : January 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: Calcipotriene 0.005% Foam||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||April 2013|
|Actual Primary Completion Date :||August 2018|
|Actual Study Completion Date :||August 2018|
Experimental: Calcipotriene 0.005% 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
- Evaluation of treatment effect and change in ISGA scores of body and scalp psoriasis (Safety and Tolerability) [ Time Frame: 56 weeks ]To 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. An evaluation of treatment effect will include changes in ISGA scores of body and scalp psoriasis from baseline. Safety will be assessed based on vital signs, reported adverse events (AEs), use of concomitant medications, and application site tolerability assessments.
- Plasma concentrations (trough) of calcipotriene [ Time Frame: 8 weeks ]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.
- Pharmacodynamic effect [ Time Frame: 2 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582932
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|Study Director:||Stuart Mudge||Sponsor GmbH|