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PK and PD Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT01766440
Recruitment Status : Completed
First Posted : January 11, 2013
Results First Posted : March 31, 2017
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
Galderma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Intervention Drug: Calcitriol 3 mcg/g ointment
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Calcitriol 3 mcg/g Ointment
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Topical application every 12 hours for 14 consecutive days

Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application

Period Title: Overall Study
Started 18
Completed 17
Not Completed 1
Arm/Group Title Calcitriol 3 mcg/g Ointment
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Topical application every 12 hours for 14 consecutive days

Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application

Overall Number of Baseline Participants 18
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[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
8.4  (3.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
8
  44.4%
Male
10
  55.6%
1.Primary Outcome
Title Cmax of Calcitriol Plasma Level
Hide Description Cmax of calcitriol plasma level at Day 14 (Peak plasma concentration of calcitriol from Day 1 to Day 14)
Time Frame Day 14
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Hide Analysis Population Description
Safety population: All enrolled subjects having received the treatment at least once.
Arm/Group Title Calcitriol 3 mcg/g Ointment
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Topical application every 12 hours for 14 consecutive days

Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: pg/mL
120.7  (31.5)
2.Primary Outcome
Title Cmin of Calcitriol Plasma Level
Hide Description Cmin of calcitriol plasma level at Day 14
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All enrolled subjects having received the treatment at least once.
Arm/Group Title Calcitriol 3 mcg/g Ointment
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Topical application every 12 hours for 14 consecutive days

Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: pg/mL
92.6  (24.2)
3.Primary Outcome
Title Tmax of Calcitriol Plasma Level
Hide Description Tmax of calcitriol plasma level at Day 14
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All enrolled subjects having received the treatment at least once.
Arm/Group Title Calcitriol 3 mcg/g Ointment
Hide Arm/Group Description:

Topical application every 12 hours for 14 consecutive days

Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: hour
1.46  (2.36)
4.Primary Outcome
Title AUC (0-6h) of Calcitriol Plasma Level
Hide Description AUC (0-6h) of calcitriol plasma level at Day 14 (Pre-dose to 6 hours post-dose)
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All enrolled subjects having received the treatment at least once.
Arm/Group Title Calcitriol 3 mcg/g Ointment
Hide Arm/Group Description:

Topical application every 12 hours for 14 consecutive days

Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: pg*h/mL
650.3  (166.8)
5.Primary Outcome
Title AUC (0-9h) of Calcitriol Plasma Level
Hide Description AUC (0-9h) of calcitriol plasma level at Day 14 (Pre-dose to 9 hours post-dose. For subjects with a body weight of <15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post-dose PK samples.)
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All enrolled subjects having received the treatment at least once.
Arm/Group Title Calcitriol 3 mcg/g Ointment
Hide Arm/Group Description:

Topical application every 12 hours for 14 consecutive days

Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: pg*h/mL
952.6  (235.9)
6.Primary Outcome
Title AUC (0-12h) of Calcitriol Plasma Level
Hide Description AUC (0-12h) of calcitriol plasma level at Day 14 (For subjects with a body weight of < 15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post dose PK samples. For subjects with a body weight of ≥ 15 kg, AUC (0-12h) was extrapolated based on the pre-dose to 9 hours post-dose PK samples.)
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All enrolled subjects having received the treatment at least once.
Arm/Group Title Calcitriol 3 mcg/g Ointment
Hide Arm/Group Description:

Topical application every 12 hours for 14 consecutive days

Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: pg*h/mL
1268.9  (307.3)
Time Frame 28 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Calcitriol 3 mcg/g Ointment
Hide Arm/Group Description

Topical application every 12 hours for 14 consecutive days

Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application

All-Cause Mortality
Calcitriol 3 mcg/g Ointment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Calcitriol 3 mcg/g Ointment
Affected / at Risk (%) # Events
Total   0/18 (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 3 mcg/g Ointment
Affected / at Risk (%) # Events
Total   9/18 (50.00%)    
Gastrointestinal disorders   
Abdominal pain upper  1/18 (5.56%)  1
Vomiting  1/18 (5.56%)  1
Infections and infestations   
Rhinitis  1/18 (5.56%)  1
Viral infection  1/18 (5.56%)  1
Injury, poisoning and procedural complications   
Sunburn  1/18 (5.56%)  1
Nervous system disorders   
Headache  2/18 (11.11%)  2
Skin and subcutaneous tissue disorders   
Pain of skin  1/18 (5.56%)  1
Pruritus  1/18 (5.56%)  1
Skin burning sensation  1/18 (5.56%)  1
Skin exfoliation  1/18 (5.56%)  1
Study was 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: NCT01766440     History of Changes
Other Study ID Numbers: RD.06. SPR.18104
First Submitted: January 9, 2013
First Posted: January 11, 2013
Results First Submitted: February 15, 2017
Results First Posted: March 31, 2017
Last Update Posted: May 18, 2017