Trial Outcomes & Findings for Fluphenazine Decanoate for Psoriasis (NCT NCT00356200)
NCT ID: NCT00356200
Last Updated: 2010-12-22
Results Overview
Change in score from 0-14 of target lesion disease activity based on scaling, erythema, and induration as determined by a physician assessor at week 4 compared to baseline (with 0 being no disease activity and 14 being maximum disease activity).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Baseline to week 4
Results posted on
2010-12-22
Participant Flow
Participant milestones
| Measure |
Cohort 1: 10 ug/ml Fluphenazine Decanoate
Receiving fluphenazine decanoate (10 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body.
|
Cohort 2: 100 ug/ml Fluphenazine Decanoate
Receiving fluphenazine decanoate (100 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body.
|
|---|---|---|
|
Cohort 1: 10 ug/ml
STARTED
|
5
|
0
|
|
Cohort 1: 10 ug/ml
COMPLETED
|
4
|
0
|
|
Cohort 1: 10 ug/ml
NOT COMPLETED
|
1
|
0
|
|
Cohort 2: 100 ug/ml (New Patients)
STARTED
|
0
|
5
|
|
Cohort 2: 100 ug/ml (New Patients)
COMPLETED
|
0
|
3
|
|
Cohort 2: 100 ug/ml (New Patients)
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1: 10 ug/ml Fluphenazine Decanoate
Receiving fluphenazine decanoate (10 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body.
|
Cohort 2: 100 ug/ml Fluphenazine Decanoate
Receiving fluphenazine decanoate (100 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body.
|
|---|---|---|
|
Cohort 1: 10 ug/ml
Lack of Efficacy
|
1
|
0
|
|
Cohort 2: 100 ug/ml (New Patients)
Lack of Efficacy
|
0
|
2
|
Baseline Characteristics
Fluphenazine Decanoate for Psoriasis
Baseline characteristics by cohort
| Measure |
Cohort 1: 10 ug/ml Fluphenazine Decanoate
n=5 Participants
Receiving fluphenazine decanoate (10 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
|
Cohort 2: 100 ug/ml Fluphenazine Decanoate
n=5 Participants
Receiving fluphenazine decanoate (100 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
41.6 years
STANDARD_DEVIATION 11.70 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 6.69 • n=7 Participants
|
39.1 years
STANDARD_DEVIATION 8.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 4Population: all 5 patients per cohort completed the visit at week 4
Change in score from 0-14 of target lesion disease activity based on scaling, erythema, and induration as determined by a physician assessor at week 4 compared to baseline (with 0 being no disease activity and 14 being maximum disease activity).
Outcome measures
| Measure |
Cohort 1, 10 ug/ml Fluphenazine Treated Lesion
n=5 Participants
lesion receiving 10 ug/ml Fluphenazine decanoate (Cohort 1)
|
Cohort 1, Placebo Treated Lesion
n=5 Participants
lesion treated with placebo (Cohort 1)
|
Cohort 2, 100 ug/ml Fluphenazine Treated Lesion
n=5 Participants
lesion receiving 100 ug/ml Fluphenazine decanoate (Cohort 2)
|
Cohort 2, Placebo Treated Lesion
n=5 Participants
lesion treated with placebo (Cohort 2)
|
|---|---|---|---|---|
|
Change in Target Lesion Score at Week 4 Compared to Baseline
|
-1 units on a scale
Standard Deviation 2.45
|
-0.8 units on a scale
Standard Deviation 2.68
|
-0.4 units on a scale
Standard Deviation 2.19
|
-1.5 units on a scale
Standard Deviation 2.40
|
SECONDARY outcome
Timeframe: Baseline to week 4Population: all 5 patients per cohort completed the visit at week 4
Target lesion pruritus as measured by the Visual Analog Scale (VAS) from 0 to 100 mm at week 4 compared to baseline (with 0 being no pruritis and 100 being maximum pruritis).
Outcome measures
| Measure |
Cohort 1, 10 ug/ml Fluphenazine Treated Lesion
n=5 Participants
lesion receiving 10 ug/ml Fluphenazine decanoate (Cohort 1)
|
Cohort 1, Placebo Treated Lesion
n=5 Participants
lesion treated with placebo (Cohort 1)
|
Cohort 2, 100 ug/ml Fluphenazine Treated Lesion
n=5 Participants
lesion receiving 100 ug/ml Fluphenazine decanoate (Cohort 2)
|
Cohort 2, Placebo Treated Lesion
n=5 Participants
lesion treated with placebo (Cohort 2)
|
|---|---|---|---|---|
|
Change in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 4 Compared to Baseline.
|
-30 mm
Standard Deviation 35.07
|
-27.2 mm
Standard Deviation 34.69
|
-18 mm
Standard Deviation 34.87
|
-32.6 mm
Standard Deviation 31.81
|
Adverse Events
Cohort 1: 10 ug/ml Fluphenazine Decanoate
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2: 100 ug/ml Fluphenazine Decanoate
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: 10 ug/ml Fluphenazine Decanoate
n=5 participants at risk
Receiving fluphenazine decanoate (10 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
|
Cohort 2: 100 ug/ml Fluphenazine Decanoate
n=5 participants at risk
Receiving fluphenazine decanoate (100 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Infections and infestations
cold/sinus symptoms
|
40.0%
2/5 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
contact dermatitis
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Eye disorders
contact lens irritation
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
cough
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
dizziness
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Injury, poisoning and procedural complications
injection site pain
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
itchy lesions
|
40.0%
2/5 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
lesion pain
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Nervous system disorders
migraine
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
pruritis
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
psoriatic lesion spreading
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
sunburn (1st degree)
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
tired
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
upper respiratory tract infection
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place