Trial Outcomes & Findings for PK and PD Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis (NCT NCT01766440)
NCT ID: NCT01766440
Last Updated: 2021-02-18
Results Overview
Cmax of calcitriol plasma level at Day 14 (Peak plasma concentration of calcitriol from Day 1 to Day 14)
COMPLETED
PHASE4
18 participants
Day 14
2021-02-18
Participant Flow
Participant milestones
| Measure |
Calcitriol 3 mcg/g Ointment
Topical application every 12 hours for 14 consecutive days
Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PK and PD Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Calcitriol 3 mcg/g Ointment
n=18 Participants
Topical application every 12 hours for 14 consecutive days
Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application
|
|---|---|
|
Age, Continuous
|
8.4 years
STANDARD_DEVIATION 3.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 14Population: Safety population: All enrolled subjects having received the treatment at least once.
Cmax of calcitriol plasma level at Day 14 (Peak plasma concentration of calcitriol from Day 1 to Day 14)
Outcome measures
| Measure |
Calcitriol 3 mcg/g Ointment
n=17 Participants
Topical application every 12 hours for 14 consecutive days
Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application
|
|---|---|
|
Cmax of Calcitriol Plasma Level
|
120.7 pg/mL
Standard Deviation 31.5
|
PRIMARY outcome
Timeframe: Day 14Population: Safety population: All enrolled subjects having received the treatment at least once.
Cmin of calcitriol plasma level at Day 14
Outcome measures
| Measure |
Calcitriol 3 mcg/g Ointment
n=17 Participants
Topical application every 12 hours for 14 consecutive days
Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application
|
|---|---|
|
Cmin of Calcitriol Plasma Level
|
92.6 pg/mL
Standard Deviation 24.2
|
PRIMARY outcome
Timeframe: Day 14Population: Safety population: All enrolled subjects having received the treatment at least once.
Tmax of calcitriol plasma level at Day 14
Outcome measures
| Measure |
Calcitriol 3 mcg/g Ointment
n=17 Participants
Topical application every 12 hours for 14 consecutive days
Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application
|
|---|---|
|
Tmax of Calcitriol Plasma Level
|
1.46 hour
Standard Deviation 2.36
|
PRIMARY outcome
Timeframe: Day 14Population: Safety population: All enrolled subjects having received the treatment at least once.
AUC (0-6h) of calcitriol plasma level at Day 14 (Pre-dose to 6 hours post-dose)
Outcome measures
| Measure |
Calcitriol 3 mcg/g Ointment
n=17 Participants
Topical application every 12 hours for 14 consecutive days
Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application
|
|---|---|
|
AUC (0-6h) of Calcitriol Plasma Level
|
650.3 pg*h/mL
Standard Deviation 166.8
|
PRIMARY outcome
Timeframe: Day 14Population: Safety population: All enrolled subjects having received the treatment at least once.
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.)
Outcome measures
| Measure |
Calcitriol 3 mcg/g Ointment
n=17 Participants
Topical application every 12 hours for 14 consecutive days
Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application
|
|---|---|
|
AUC (0-9h) of Calcitriol Plasma Level
|
952.6 pg*h/mL
Standard Deviation 235.9
|
PRIMARY outcome
Timeframe: Day 14Population: Safety population: All enrolled subjects having received the treatment at least once.
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.)
Outcome measures
| Measure |
Calcitriol 3 mcg/g Ointment
n=17 Participants
Topical application every 12 hours for 14 consecutive days
Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application
|
|---|---|
|
AUC (0-12h) of Calcitriol Plasma Level
|
1268.9 pg*h/mL
Standard Deviation 307.3
|
Adverse Events
Calcitriol 3 mcg/g Ointment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Calcitriol 3 mcg/g Ointment
n=18 participants at risk
Topical application every 12 hours for 14 consecutive days
Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
1/18 • Number of events 1 • 28 days
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 1 • 28 days
|
|
Infections and infestations
Rhinitis
|
5.6%
1/18 • Number of events 1 • 28 days
|
|
Infections and infestations
Viral infection
|
5.6%
1/18 • Number of events 1 • 28 days
|
|
Injury, poisoning and procedural complications
Sunburn
|
5.6%
1/18 • Number of events 1 • 28 days
|
|
Nervous system disorders
Headache
|
11.1%
2/18 • Number of events 2 • 28 days
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
5.6%
1/18 • Number of events 1 • 28 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • Number of events 1 • 28 days
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
5.6%
1/18 • Number of events 1 • 28 days
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
5.6%
1/18 • Number of events 1 • 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place