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

NCT02125279 | Completed Phase 4 Results DMC

• 1 other identifier: RD.06.SPR.18131
• Study Type: interventional
• Target: 54
• Locations: 5 countries
• Sites: 16

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.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (21)

• 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

• 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

• 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

• 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

• 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

• 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)

• 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

• 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

• 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)

• 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

• 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

• 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

• 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

• 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)

• 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

• 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

• 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

• 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

• 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

• 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)

• 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 Outcomes (3)

• 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)

• Change From Baseline in Pruritus Score at Each Visit

  Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)

• Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit

  Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)

Study Arms (1)

Calcitriol ointment

EXPERIMENTAL

Drug: Calcitriol

Interventions

Calcitriol DRUG

Calcitriol ointment

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female 2 to 16 years and 11 months of age
• Clinical diagnosis of stable mild to moderate plaque psoriasis

You may not qualify if:

• Other forms of psoriasis
• Hypercalcemia
• Past history of kidney stones
• Vitamin D deficiency
• Other concomitant dermatological disease

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (16)

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

Location

Northwest Arkansas Clinical Trials Center, PLLC

Rogers, Arkansas, 72758, United States

Location

Advanced Skincare Surgery & Medcenter

Burbank, California, 91505, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Shideler Clinical Research Center

Carmel, Indiana, 46032, United States

Location

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, 46256, United States

Location

Montefiore Medical Center

New York, New York, 10467, United States

Location

Arlington Research Center for Dermatology

Arlington, Texas, 76011, United States

Location

UZ Gent Dermatology Department

Ghent, 9000, Belgium

Location

Lynderm Research Inc.

Markham, Ontario, L3P1X2, Canada

Location

CHU Sainte-Justine

Montreal, Quebec, H3T1C5, Canada

Location

Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

University Hospital Carl Gustav Carus

Dresden, 01307, Germany

Location

Universitäts-Hautklinik Mainz, Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Padova University Hospital

Padua, 35128, Italy

Location

University of Parma

Parma, 43126, Italy

Location

MeSH Terms

Interventions

Calcitriol

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Study Officials

• Michael Graeber, MD

  Galderma R&D, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 29, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: February 18, 2021
• Results First Posted: November 29, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); BE (1); US (8); CA (2); DE (3)