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.
Brief Title
Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
Categories
Completion Date
Completion Date Type
Actual
Conditions
Psoriasis Vulgaris
Eligibility Criteria
Inclusion Criteria:
* Male or female 2 to 16 years and 11 months of age
* Clinical diagnosis of stable mild to moderate plaque psoriasis
Exclusion Criteria:
* Other forms of psoriasis
* Hypercalcemia
* Past history of kidney stones
* Vitamin D deficiency
* Other concomitant dermatological disease
* Male or female 2 to 16 years and 11 months of age
* Clinical diagnosis of stable mild to moderate plaque psoriasis
Exclusion Criteria:
* Other forms of psoriasis
* Hypercalcemia
* Past history of kidney stones
* Vitamin D deficiency
* Other concomitant dermatological disease
Inclusion Criteria
Inclusion Criteria:
* Male or female 2 to 16 years and 11 months of age
* Clinical diagnosis of stable mild to moderate plaque psoriasis
* Male or female 2 to 16 years and 11 months of age
* Clinical diagnosis of stable mild to moderate plaque psoriasis
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
16 Years
Minimum Age
2 Years
NCT Id
NCT02125279
Org Class
Industry
Org Full Name
Galderma R&D
Org Study Id
RD.06.SPR.18131
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Multicenter Open Label Uncontrolled Study of the Long Term Safety and Efficacy of Calcitriol 3 mcg/g Ointment Applied Twice Daily for 26 Weeks in Pediatric Subjects (2 to 16 Years and 11 mo of Age) With Mild to Moderate Plaque Psoriasis
Primary Outcomes
Outcome Description
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 4 were reported.
Outcome Measure
Change From Screening in Serum Albumin Levels at Week 4
Outcome Time Frame
Screening, Week 4
Outcome Description
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 8 were reported.
Outcome Measure
Change From Screening in Serum Albumin Levels at Week 8
Outcome Time Frame
Screening, Week 8
Outcome Description
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 12 were reported.
Outcome Measure
Change From Screening in Serum Albumin Levels at Week 12
Outcome Time Frame
Screening, Week 12
Outcome Description
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 20 were reported.
Outcome Measure
Change From Screening in Serum Albumin Levels at Week 20
Outcome Time Frame
Screening, Week 20
Outcome Description
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 26 were reported.
Outcome Measure
Change From Screening in Serum Albumin Levels at Week 26
Outcome Time Frame
Screening, Week 26
Outcome Description
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 30 were reported.
Outcome Measure
Change From Screening in Serum Albumin Levels at Week 30 (Follow-up)
Outcome Time Frame
Screening, Week 30 (Follow-up)
Outcome Description
Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 12 were reported.
Outcome Measure
Change From Screening in Urine Calcium/Creatinine Ratio at Week 12
Outcome Time Frame
Screening, Week 12
Outcome Description
Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 26 were reported.
Outcome Measure
Change From Screening in Urine Calcium/Creatinine Ratio at Week 26
Outcome Time Frame
Screening, Week 26
Outcome Description
Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 30 were reported.
Outcome Measure
Change From Screening in Urine Calcium/Creatinine Ratio at Week 30 (Follow-up)
Outcome Time Frame
Screening, Week 30 (Follow-up)
Outcome Description
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 4 were reported.
Outcome Measure
Change From Screening in Serum Phosphate Levels at Week 4
Outcome Time Frame
Screening, Week 4
Outcome Description
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 12 were reported.
Outcome Measure
Change From Screening in Serum Phosphate Levels at Week 12
Outcome Time Frame
Screening, Week 12
Outcome Description
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 20 were reported.
Outcome Measure
Change From Screening in Serum Phosphate Levels at Week 20
Outcome Time Frame
Screening, Week 20
Outcome Description
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 26 were reported.
Outcome Measure
Change From Screening in Serum Phosphate Levels at Week 26
Outcome Time Frame
Screening, Week 26
Outcome Description
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 30 were reported.
Outcome Measure
Change From Screening in Serum Phosphate Levels at Week 30 (Follow-up)
Outcome Time Frame
Screening, Week 30 (Follow-up)
Outcome Description
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 4 were reported.
Outcome Measure
Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 4
Outcome Time Frame
Screening, Week 4
Outcome Description
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 8 were reported.
Outcome Measure
Change From Screening in Serum Parathyroid Hormone Levels at Week 8
Outcome Time Frame
Screening, Week 8
Outcome Description
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 12 were reported.
Outcome Measure
Change From Screening in Serum Parathyroid Hormone Levels at Week 12
Outcome Time Frame
Screening, Week 12
Outcome Description
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 20 were reported.
Outcome Measure
Change From Screening in Serum Parathyroid Hormone Levels at Week 20
Outcome Time Frame
Screening, Week 20
Outcome Description
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 26 were reported.
Outcome Measure
Change From Screening in Serum Parathyroid Hormone Levels at Week 26
Outcome Time Frame
Screening, Week 26
Outcome Description
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 30 were reported.
Outcome Measure
Change From Screening in Serum Parathyroid Hormone Levels at Week 30 (Follow-up)
Outcome Time Frame
Screening, Week 30 (Follow-up)
Outcome Description
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.
Outcome Measure
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Outcome Time Frame
Up to Week 30
Secondary Outcomes
Outcome Description
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).
Outcome Time Frame
Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
Outcome Measure
Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit
Outcome Description
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.
Outcome Time Frame
Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
Outcome Measure
Change From Baseline in Pruritus Score at Each Visit
Outcome Description
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.
Outcome Time Frame
Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
Outcome Measure
Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
16
Minimum Age Number (converted to Years and rounded down)
2
Investigators
Investigator Type
Principal Investigator
Investigator Name
Holly Kanavy
Investigator Email
HKanavy@montefiore.org
Investigator Phone
866-633-8255 / 718-230-2997 / 510-996-0741
MeSH Terms
CALCITRIOL
DIHYDROXYCHOLECALCIFEROLS
HYDROXYCHOLECALCIFEROLS
CHOLECALCIFEROL
CHOLESTENES
CHOLESTANES
STEROIDS
FUSED-RING COMPOUNDS
POLYCYCLIC COMPOUNDS
STEROLS
VITAMIN D
SECOSTEROIDS
MEMBRANE LIPIDS
LIPIDS