Trial Outcomes & Findings for Plaque Psoriasis Study in Pediatric Subjects (NCT NCT02186665)
NCT ID: NCT02186665
Last Updated: 2021-02-18
Results Overview
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
COMPLETED
PHASE4
19 participants
Baseline to Week 8
2021-02-18
Participant Flow
Participant milestones
| Measure |
Calcitriol Ointment
Calcitriol 3 mcg/g Ointment
|
Placebo
Placebo comparator
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
11
|
|
Overall Study
COMPLETED
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Plaque Psoriasis Study in Pediatric Subjects
Baseline characteristics by cohort
| Measure |
Calcitriol Ointment
n=8 Participants
Calcitriol 3 mcg/g Ointment
|
Placebo
n=11 Participants
Placebo comparator
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.6 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
9.8 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
9.7 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8Population: ITT: All randomized subjects to whom study medication was dispensed.
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
Outcome measures
| Measure |
Calcitriol Ointment
n=8 Participants
Calcitriol 3 mcg/g Ointment
|
Placebo
n=11 Participants
Placebo Comparator
|
|---|---|---|
|
Success of Investigator's Global Assessment (IGA)
|
3 Participants
|
7 Participants
|
Adverse Events
Calcitriol Ointment
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Calcitriol Ointment
n=8 participants at risk
Calcitriol 3 mcg/g Ointment
|
Placebo
n=11 participants at risk
Placebo Comparator
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
1/8 • Number of events 1 • 16 weeks
|
0.00%
0/11 • 16 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Number of events 2 • 16 weeks
|
0.00%
0/11 • 16 weeks
|
|
Infections and infestations
Conjuctivitis bacterial
|
12.5%
1/8 • Number of events 1 • 16 weeks
|
0.00%
0/11 • 16 weeks
|
|
Infections and infestations
Gastroenteritis
|
12.5%
1/8 • Number of events 1 • 16 weeks
|
0.00%
0/11 • 16 weeks
|
|
Infections and infestations
Laryngitis
|
0.00%
0/8 • 16 weeks
|
9.1%
1/11 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Lice infestation
|
12.5%
1/8 • Number of events 1 • 16 weeks
|
0.00%
0/11 • 16 weeks
|
|
Infections and infestations
Molluscum contagiosum
|
12.5%
1/8 • Number of events 1 • 16 weeks
|
0.00%
0/11 • 16 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • 16 weeks
|
18.2%
2/11 • Number of events 4 • 16 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • 16 weeks
|
9.1%
1/11 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • 16 weeks
|
9.1%
1/11 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Viral infection
|
0.00%
0/8 • 16 weeks
|
9.1%
1/11 • Number of events 1 • 16 weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/8 • 16 weeks
|
9.1%
1/11 • Number of events 1 • 16 weeks
|
|
Investigations
Blood pressure increased
|
0.00%
0/8 • 16 weeks
|
9.1%
1/11 • Number of events 2 • 16 weeks
|
|
Investigations
Urine calcium/creatinine ratio increased
|
0.00%
0/8 • 16 weeks
|
9.1%
1/11 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • 16 weeks
|
9.1%
1/11 • Number of events 1 • 16 weeks
|
|
Renal and urinary disorders
Hypercalciuria
|
0.00%
0/8 • 16 weeks
|
9.1%
1/11 • Number of events 1 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • 16 weeks
|
18.2%
2/11 • Number of events 2 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8 • Number of events 1 • 16 weeks
|
0.00%
0/11 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • 16 weeks
|
9.1%
1/11 • Number of events 1 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/8 • 16 weeks
|
9.1%
1/11 • Number of events 1 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
25.0%
2/8 • Number of events 2 • 16 weeks
|
0.00%
0/11 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place