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Plaque Psoriasis Study in Pediatric Subjects

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ClinicalTrials.gov Identifier: NCT02186665
Recruitment Status : Completed
First Posted : July 10, 2014
Results First Posted : March 31, 2017
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Galderma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Drug: calcitriol ointment
Drug: placebo comparator
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Calcitriol Ointment Placebo
Hide Arm/Group Description Calcitriol 3 mcg/g Ointment Placebo comparator
Period Title: Overall Study
Started 8 11
Completed 8 10
Not Completed 0 1
Arm/Group Title Calcitriol Ointment Placebo Total
Hide Arm/Group Description Calcitriol 3 mcg/g Ointment Placebo comparator Total of all reporting groups
Overall Number of Baseline Participants 8 11 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 11 participants 19 participants
9.6  (1.8) 9.8  (1.8) 9.7  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 11 participants 19 participants
Female
5
  62.5%
7
  63.6%
12
  63.2%
Male
3
  37.5%
4
  36.4%
7
  36.8%
1.Primary Outcome
Title Success of Investigator's Global Assessment (IGA)
Hide Description

The number of subjects with a minimum improvement of 2 grades from baseline in the IGA score and a severity rating of 0 (clear) of 1 (almost clear) at Week 8 (LOCF).

The IGA was evaluated at each visit on the following 0 to 4 point scale:

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 Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT: All randomized subjects to whom study medication was dispensed.
Arm/Group Title Calcitriol Ointment Placebo
Hide Arm/Group Description:
Calcitriol 3 mcg/g Ointment
Placebo Comparator
Overall Number of Participants Analyzed 8 11
Measure Type: Count of Participants
Unit of Measure: Participants
3
  37.5%
7
  63.6%
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Calcitriol Ointment Placebo
Hide Arm/Group Description Calcitriol 3 mcg/g Ointment Placebo Comparator
All-Cause Mortality
Calcitriol Ointment Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Calcitriol Ointment Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Calcitriol Ointment Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/8 (75.00%)      8/11 (72.73%)    
Gastrointestinal disorders     
Abdominal pain upper  1/8 (12.50%)  1 0/11 (0.00%)  0
Diarrhea  1/8 (12.50%)  2 0/11 (0.00%)  0
Infections and infestations     
Conjuctivitis bacterial  1/8 (12.50%)  1 0/11 (0.00%)  0
Gastroenteritis  1/8 (12.50%)  1 0/11 (0.00%)  0
Laryngitis  0/8 (0.00%)  0 1/11 (9.09%)  1
Lice infestation  1/8 (12.50%)  1 0/11 (0.00%)  0
Molluscum contagiosum  1/8 (12.50%)  1 0/11 (0.00%)  0
Nasopharyngitis  0/8 (0.00%)  0 2/11 (18.18%)  4
Upper respiratory tract infection  0/8 (0.00%)  0 1/11 (9.09%)  1
Urinary tract infection  0/8 (0.00%)  0 1/11 (9.09%)  1
Viral infection  0/8 (0.00%)  0 1/11 (9.09%)  1
Injury, poisoning and procedural complications     
Arthropod bite  0/8 (0.00%)  0 1/11 (9.09%)  1
Investigations     
Blood pressure increased  0/8 (0.00%)  0 1/11 (9.09%)  2
Urine calcium/creatinine ratio increased  0/8 (0.00%)  0 1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders     
Myalgia  0/8 (0.00%)  0 1/11 (9.09%)  1
Renal and urinary disorders     
Hypercalciuria  0/8 (0.00%)  0 1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  0/8 (0.00%)  0 2/11 (18.18%)  2
Oropharyngeal pain  1/8 (12.50%)  1 0/11 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritus  0/8 (0.00%)  0 1/11 (9.09%)  1
Psoriasis  0/8 (0.00%)  0 1/11 (9.09%)  1
Skin irritation  2/8 (25.00%)  2 0/11 (0.00%)  0
Study terminated early due to slow enrollment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Michael Graeber
Organization: Galderma
Phone: (817)961-5000
Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT02186665     History of Changes
Other Study ID Numbers: RD.06.SPR.18132
First Submitted: July 8, 2014
First Posted: July 10, 2014
Results First Submitted: February 15, 2017
Results First Posted: March 31, 2017
Last Update Posted: May 9, 2017