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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Johnson Dermatology
Fort Smith, Arkansas, United States
Northwest Arkansas Clinical Trials Center, PLLC
Rogers, Arkansas, United States
Change From Screening in Serum Albumin Levels at Week 4
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 4 were reported.
Time frame: Screening, Week 4
Change From Screening in Serum Albumin Levels at Week 8
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 8 were reported.
Time frame: Screening, Week 8
Change From Screening in Serum Albumin Levels at Week 12
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 12 were reported.
Time frame: Screening, Week 12
Change From Screening in Serum Albumin Levels at Week 20
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 20 were reported.
Time frame: Screening, Week 20
Change From Screening in Serum Albumin Levels at Week 26
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 26 were reported.
Time frame: Screening, Week 26
Change From Screening in Serum Albumin Levels at 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.
Time frame: Screening, Week 30 (Follow-up)
Change From Screening in Urine Calcium/Creatinine Ratio at 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.
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Advanced Skincare Surgery & Medcenter
Burbank, California, United States
University of South Florida
Tampa, Florida, United States
Shideler Clinical Research Center
Carmel, Indiana, United States
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, United States
Montefiore Medical Center
New York, New York, United States
Arlington Research Center for Dermatology
Arlington, Texas, United States
UZ Gent Dermatology Department
Ghent, Belgium
Lynderm Research Inc.
Markham, Ontario, Canada
...and 6 more locations
Time frame: Screening, Week 12
Change From Screening in Urine Calcium/Creatinine Ratio at 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.
Time frame: Screening, Week 26
Change From Screening in Urine Calcium/Creatinine Ratio at 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.
Time frame: Screening, Week 30 (Follow-up)
Change From Screening in Serum Phosphate Levels at Week 4
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 4 were reported.
Time frame: Screening, Week 4
Change From Screening in Serum Phosphate Levels at Week 12
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 12 were reported.
Time frame: Screening, Week 12
Change From Screening in Serum Phosphate Levels at Week 20
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 20 were reported.
Time frame: Screening, Week 20
Change From Screening in Serum Phosphate Levels at Week 26
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 26 were reported.
Time frame: Screening, Week 26
Change From Screening in Serum Phosphate Levels at 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.
Time frame: Screening, Week 30 (Follow-up)
Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 4
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 4 were reported.
Time frame: Screening, Week 4
Change From Screening in Serum Parathyroid Hormone Levels at Week 8
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 8 were reported.
Time frame: Screening, Week 8
Change From Screening in Serum Parathyroid Hormone Levels at Week 12
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 12 were reported.
Time frame: Screening, Week 12
Change From Screening in Serum Parathyroid Hormone Levels at Week 20
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 20 were reported.
Time frame: Screening, Week 20
Change From Screening in Serum Parathyroid Hormone Levels at Week 26
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 26 were reported.
Time frame: Screening, Week 26
Change From Screening in Serum Parathyroid Hormone Levels at 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.
Time frame: Screening, Week 30 (Follow-up)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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.
Time frame: Up to Week 30
Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit
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).
Time frame: Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
Change From Baseline in Pruritus Score at Each Visit
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.
Time frame: Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit
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.
Time frame: Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)