Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis

Psoriasis Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125279
• Other study ID #: RD.06.SPR.18131
• Status: Completed
• Phase: Phase 4
• Start date: May 2014
• Est. completion date: May 2018

Study information

• Verified date: December 2019
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• Calcitriol

Locations

Country	Name	City	State
Belgium	UZ Gent Dermatology Department	Gent
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	CHU Sainte-Justine	Montreal	Quebec
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	University Hospital Carl Gustav Carus	Dresden
Germany	Universitäts-Hautklinik Mainz, Johannes Gutenberg-Universität Mainz	Mainz
Italy	Padova University Hospital	Padova
Italy	University of Parma	Parma
United States	Arlington Research Center for Dermatology	Arlington	Texas
United States	Advanced Skincare Surgery & Medcenter	Burbank	California
United States	Shideler Clinical Research Center	Carmel	Indiana
United States	Johnson Dermatology	Fort Smith	Arkansas
United States	Dawes Fretzin Clinical Research Group	Indianapolis	Indiana
United States	Montefiore Medical Center	New York	New York
United States	Northwest Arkansas Clinical Trials Center, PLLC	Rogers	Arkansas
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Screening, Week 4
Primary	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.	Screening, Week 8
Primary	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.	Screening, Week 12
Primary	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.	Screening, Week 20
Primary	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.	Screening, Week 26
Primary	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.	Screening, Week 30 (Follow-up)
Primary	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.	Screening, Week 12
Primary	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.	Screening, Week 26
Primary	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.	Screening, Week 30 (Follow-up)
Primary	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.	Screening, Week 4
Primary	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.	Screening, Week 12
Primary	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.	Screening, Week 20
Primary	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.	Screening, Week 26
Primary	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.	Screening, Week 30 (Follow-up)
Primary	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.	Screening, Week 4
Primary	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.	Screening, Week 8
Primary	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.	Screening, Week 12
Primary	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.	Screening, Week 20
Primary	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.	Screening, Week 26
Primary	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.	Screening, Week 30 (Follow-up)
Primary	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.	Up to Week 30
Secondary	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).	Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
Secondary	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.	Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
Secondary	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.	Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)