Trial Outcomes & Findings for Fluphenazine Hydrochloride for Psoriasis (NCT NCT00929578)

Last Updated: 2017-03-31

Results Overview

Actual change in target lesion score comparing 4 week score with baseline score. Improvement is positive, worsening is negative. Target lesions scores range from 0 (no disease) to 12 (severe disease), and are scored based on the sum of erythema (0-4), induration (0-4) and scale (0-4) scores.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

4 weeks

Results posted on

2017-03-31

Participant Flow

Recruitment from a dermatology clinic of a tertiary care medical center. Recruitment dates from Oct 2008 to Sep 2010.

Participant milestones

Participant milestones
Measure	All Study Participants The sterile placebo: Bacteriostatic Sodium Chloride for Injection. Same subject will also receive dose in other arm of fluphenazine. This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fluphenazine Hydrochloride for Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants - Fluphenazine n=15 Participants This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	51.5 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: All participants who successfully were enrolled.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants The sterile placebo: Bacteriostatic Sodium Chloride for Injection.	Fluphenazine n=15 Participants This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.	1 Week Post Dose Participants with fluphenazine serum levels \> 0.200ng/ml
Change in Target Lesion Scoring Evaluated at Baseline and 4 Weeks	-1.4 units on a scale Standard Deviation 1.5	-1.4 units on a scale Standard Deviation 1.8	—

SECONDARY outcome

Timeframe: 4 weeks

Population: Participants who completed entire trial.

Visual Analog Scale (VAS) score for pruritus. Subjective measurement of pruritus on an analog scale with a single mark denoting self-perceived pruritus: Minimum 0mm for no itch, Maximum 100mm for worst itch imaginable. Scores are measured in millimeters. This secondary outcome is a percentage improvement from baseline score for pruritus. Improvement is negative, worsening is positive.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants The sterile placebo: Bacteriostatic Sodium Chloride for Injection.	Fluphenazine n=15 Participants This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.	1 Week Post Dose Participants with fluphenazine serum levels \> 0.200ng/ml
Change in the Target Lesion Visual Analog Scale (VAS) Score for Pruritus Evaluated at Baseline and 4 Weeks	0.86 percentage of baseline pruritus Standard Deviation 15.0	-2.16 percentage of baseline pruritus Standard Deviation 22.9	—

SECONDARY outcome

Timeframe: 8 weeks

Population: All participants who completed enrollment.

adverse events will be recorded and monitored. Adverse events will be noted in a separate chart.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants The sterile placebo: Bacteriostatic Sodium Chloride for Injection.	Fluphenazine This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.	1 Week Post Dose Participants with fluphenazine serum levels \> 0.200ng/ml
Safety Outcome Measures	12 All Study Participant	—	—

SECONDARY outcome

Timeframe: 1 week

Population: All participants who were enrolled and completed baseline and week 1 were included.

Number of participants with fluphenazine serum levels \> 0.200ng/ml, at baseline, 2 hours post dose and 1 week post dose.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants The sterile placebo: Bacteriostatic Sodium Chloride for Injection.	Fluphenazine n=15 Participants This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.	1 Week Post Dose n=15 Participants Participants with fluphenazine serum levels \> 0.200ng/ml
Fluphenazine Serum Levels Measured at Baseline, 2 Hours Post Dose and 1 Week Post Dose.	0 participants	2 participants	2 participants

Adverse Events

All Study Participants

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Study Participants n=15 participants at risk This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion. All participants received medication, as the study was a split study, and subjects received placebo on one side and injection of fluphenazine on other side
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	13.3% 2/15 • Number of events 2 • 1 year, 10 months
General disorders Difficulty Sleeping	13.3% 2/15 • Number of events 2 • 1 year, 10 months
General disorders Fatigue	13.3% 2/15 • Number of events 2 • 1 year, 10 months
Gastrointestinal disorders Nausea	13.3% 2/15 • Number of events 2 • 1 year, 10 months
Gastrointestinal disorders Vomiting	13.3% 2/15 • Number of events 2 • 1 year, 10 months
Skin and subcutaneous tissue disorders Xerosis	6.7% 1/15 • Number of events 1 • 1 year, 10 months
Eye disorders Dry Eyes	6.7% 1/15 • Number of events 1 • 1 year, 10 months
Skin and subcutaneous tissue disorders Injection Site Pain	13.3% 2/15 • Number of events 2 • 1 year, 10 months
Musculoskeletal and connective tissue disorders Sprained Medial Collateral Ligament	6.7% 1/15 • Number of events 1 • 1 year, 10 months
Skin and subcutaneous tissue disorders Nighttime Sweats	6.7% 1/15 • Number of events 1 • 1 year, 10 months
Skin and subcutaneous tissue disorders Bruise, Upper left arm	6.7% 1/15 • Number of events 1 • 1 year, 10 months
Psychiatric disorders Nightmares	6.7% 1/15 • Number of events 1 • 1 year, 10 months
General disorders Dry mouth	6.7% 1/15 • Number of events 1 • 1 year, 10 months
Musculoskeletal and connective tissue disorders Gout	6.7% 1/15 • Number of events 1 • 1 year, 10 months
Skin and subcutaneous tissue disorders Blisters	6.7% 1/15 • Number of events 1 • 1 year, 10 months
Musculoskeletal and connective tissue disorders Ankle Pain	6.7% 1/15 • Number of events 1 • 1 year, 10 months
General disorders Unusual dreams	13.3% 2/15 • Number of events 2 • 1 year, 10 months
Injury, poisoning and procedural complications Abrasion	6.7% 1/15 • Number of events 1 • 1 year, 10 months

Additional Information

Alice Gottlieb, MD PhD

Tufts Medical Center

Phone: 617-636-7462

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place