Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
- Registration Number
- NCT02125279
- Lead Sponsor
- Galderma R&D
- Brief Summary
The objective of this study is to evaluate the safety and efficacy of up to 26 weeks of treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat pediatric subjects (2 to 16 years and 11 months of age) with mild to moderate plaque psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- Male or female 2 to 16 years and 11 months of age
- Clinical diagnosis of stable mild to moderate plaque psoriasis
- Other forms of psoriasis
- Hypercalcemia
- Past history of kidney stones
- Vitamin D deficiency
- Other concomitant dermatological disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Calcitriol ointment Calcitriol -
- Primary Outcome Measures
Name Time Method Change From Screening in Serum Albumin Levels at Week 4 Screening, Week 4 Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 4 were reported.
Change From Screening in Serum Albumin Levels at Week 12 Screening, Week 12 Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 12 were reported.
Change From Screening in Serum Albumin Levels at Week 26 Screening, Week 26 Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 26 were reported.
Change From Screening in Serum Albumin Levels at Week 30 (Follow-up) Screening, Week 30 (Follow-up) Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 30 were reported.
Change From Screening in Urine Calcium/Creatinine Ratio at Week 30 (Follow-up) Screening, Week 30 (Follow-up) Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 30 were reported.
Change From Screening in Serum Albumin Levels at Week 8 Screening, Week 8 Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 8 were reported.
Change From Screening in Urine Calcium/Creatinine Ratio at Week 26 Screening, Week 26 Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 26 were reported.
Change From Screening in Serum Albumin Levels at Week 20 Screening, Week 20 Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 20 were reported.
Change From Screening in Serum Phosphate Levels at Week 12 Screening, Week 12 Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 12 were reported.
Change From Screening in Serum Parathyroid Hormone Levels at Week 26 Screening, Week 26 Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 26 were reported.
Change From Screening in Serum Phosphate Levels at Week 4 Screening, Week 4 Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 4 were reported.
Change From Screening in Serum Phosphate Levels at Week 20 Screening, Week 20 Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 20 were reported.
Change From Screening in Serum Phosphate Levels at Week 26 Screening, Week 26 Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 26 were reported.
Change From Screening in Serum Phosphate Levels at Week 30 (Follow-up) Screening, Week 30 (Follow-up) Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 30 were reported.
Change From Screening in Serum Parathyroid Hormone Levels at Week 8 Screening, Week 8 Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 8 were reported.
Change From Screening in Serum Parathyroid Hormone Levels at Week 12 Screening, Week 12 Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 12 were reported.
Change From Screening in Urine Calcium/Creatinine Ratio at Week 12 Screening, Week 12 Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 12 were reported.
Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 4 Screening, Week 4 Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 4 were reported.
Change From Screening in Serum Parathyroid Hormone Levels at Week 20 Screening, Week 20 Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 20 were reported.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Up to Week 30 An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with an onset date on or after the first application of the study drug.
Change From Screening in Serum Parathyroid Hormone Levels at Week 30 (Follow-up) Screening, Week 30 (Follow-up) Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 30 were reported.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up) Percent BSA was calculated by modified rules of nines (pediatric participants). Estimate were made from the following for a child up to the age of one year: head and neck total for front and back - 18%; thorax and abdomen-front -18%; thorax and abdomen-back - 18%; each upper limb total for front and back - 9%; each lower limb total for front and back - 14%. For over the age of one year, the relative percentage of BSA changes as follows: the head decreases by 1% per year and the lower limbs increase by 0.5% per year. By the age of ten years, the relative proportions assume the values for adult BSA as follows: perineum becomes 1%; each lower limb becomes a total of 18% front and back; head and neck become 9% total for front and back.
Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit Weeks 4, 8, 12, 20, 26 and 30 (Follow-up) The IGA is a 0 to 4 point scale. Where, 0 = clear (no signs of psoriasis except for residual hypopigmentation/hyperpigmentation); 1 = almost clear (just perceptible erythema, no induration, and no scaling); 2 = mild (mild erythema, no induration, and mild or no scaling); 3 = moderate (moderate erythema, mild induration, and mild or no scaling); 4 = severe (severe erythema, moderate to severe induration, and scaling of any degree).
Change From Baseline in Pruritus Score at Each Visit Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up) Pruritus was scored on a 0 to 4 point scale. Where, 0 = none (no-itching); 1 = mild (slight itching, not really bothersome); 2 = moderate (definite itching that is somewhat bothersome without loss of sleep); 3 = severe (intense itching that has caused pronounced discomfort, night rest interrupted); 4 = very severe (very severe itching that has caused pronounced discomfort during the night and daily activities). Positive change from baseline indicate worsening of indication.
Trial Locations
- Locations (16)
Johnson Dermatology
🇺🇸Fort Smith, Arkansas, United States
Advanced Skincare Surgery & Medcenter
🇺🇸Burbank, California, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Dawes Fretzin Clinical Research Group
🇺🇸Indianapolis, Indiana, United States
Northwest Arkansas Clinical Trials Center, PLLC
🇺🇸Rogers, Arkansas, United States
Shideler Clinical Research Center
🇺🇸Carmel, Indiana, United States
Arlington Research Center for Dermatology
🇺🇸Arlington, Texas, United States
UZ Gent Dermatology Department
🇧🇪Gent, Belgium
CHU Sainte-Justine
🇨🇦Montreal, Quebec, Canada
Charité Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Lynderm Research Inc.
🇨🇦Markham, Ontario, Canada
Universitäts-Hautklinik Mainz, Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Padova University Hospital
🇮🇹Padova, Italy
University Hospital Carl Gustav Carus
🇩🇪Dresden, Germany
University of Parma
🇮🇹Parma, Italy
Montefiore Medical Center
🇺🇸New York, New York, United States