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

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ClinicalTrials.gov Identifier: NCT02125279
Recruitment Status : Completed
First Posted : April 29, 2014
Results First Posted : November 29, 2019
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: Calcitriol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2014
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Calcitriol

Arm Intervention/treatment
Experimental: Calcitriol ointment Drug: Calcitriol



Primary Outcome Measures :
  1. Change From Screening in Serum Albumin Levels at Week 4 [ Time Frame: 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.

  2. Change From Screening in Serum Albumin Levels at Week 8 [ Time Frame: 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.

  3. Change From Screening in Serum Albumin Levels at Week 12 [ Time Frame: 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.

  4. Change From Screening in Serum Albumin Levels at Week 20 [ Time Frame: 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.

  5. Change From Screening in Serum Albumin Levels at Week 26 [ Time Frame: 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.

  6. Change From Screening in Serum Albumin Levels at Week 30 (Follow-up) [ Time Frame: 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.

  7. Change From Screening in Urine Calcium/Creatinine Ratio at Week 12 [ Time Frame: 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.

  8. Change From Screening in Urine Calcium/Creatinine Ratio at Week 26 [ Time Frame: 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.

  9. Change From Screening in Urine Calcium/Creatinine Ratio at Week 30 (Follow-up) [ Time Frame: 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.

  10. Change From Screening in Serum Phosphate Levels at Week 4 [ Time Frame: 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.

  11. Change From Screening in Serum Phosphate Levels at Week 12 [ Time Frame: 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.

  12. Change From Screening in Serum Phosphate Levels at Week 20 [ Time Frame: 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.

  13. Change From Screening in Serum Phosphate Levels at Week 26 [ Time Frame: 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.

  14. Change From Screening in Serum Phosphate Levels at Week 30 (Follow-up) [ Time Frame: 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.

  15. Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 4 [ Time Frame: 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.

  16. Change From Screening in Serum Parathyroid Hormone Levels at Week 8 [ Time Frame: 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.

  17. Change From Screening in Serum Parathyroid Hormone Levels at Week 12 [ Time Frame: 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.

  18. Change From Screening in Serum Parathyroid Hormone Levels at Week 20 [ Time Frame: 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.

  19. Change From Screening in Serum Parathyroid Hormone Levels at Week 26 [ Time Frame: 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.

  20. Change From Screening in Serum Parathyroid Hormone Levels at Week 30 (Follow-up) [ Time Frame: 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.

  21. Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit [ Time Frame: 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).

  2. Change From Baseline in Pruritus Score at Each Visit [ Time Frame: 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.

  3. Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02125279


Locations
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United States, Arkansas
Johnson Dermatology
Fort Smith, Arkansas, United States, 72916
Northwest Arkansas Clinical Trials Center, PLLC
Rogers, Arkansas, United States, 72758
United States, California
Advanced Skincare Surgery & Medcenter
Burbank, California, United States, 91505
United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
United States, Indiana
Shideler Clinical Research Center
Carmel, Indiana, United States, 46032
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, United States, 46256
United States, New York
Montefiore Medical Center
New York, New York, United States, 10467
United States, Texas
Arlington Research Center for Dermatology
Arlington, Texas, United States, 76011
Belgium
UZ Gent Dermatology Department
Gent, Belgium, 9000
Canada, Ontario
Lynderm Research Inc.
Markham, Ontario, Canada, L3P1X2
Canada, Quebec
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T1C5
Germany
Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
University Hospital Carl Gustav Carus
Dresden, Germany, 01307
Universitäts-Hautklinik Mainz, Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
Italy
Padova University Hospital
Padova, Italy, 35128
University of Parma
Parma, Italy, 43126
Sponsors and Collaborators
Galderma R&D
Investigators
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Study Director: Michael Graeber, MD Galderma R&D, LLC
  Study Documents (Full-Text)

Documents provided by Galderma R&D:
Study Protocol  [PDF] January 7, 2016
Statistical Analysis Plan  [PDF] May 27, 2014

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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT02125279    
Other Study ID Numbers: RD.06.SPR.18131
First Posted: April 29, 2014    Key Record Dates
Results First Posted: November 29, 2019
Last Update Posted: February 18, 2021
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcitriol
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents