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Fluphenazine Hydrochloride for Psoriasis (FP-CL2)

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ClinicalTrials.gov Identifier: NCT00929578
Recruitment Status : Completed
First Posted : June 29, 2009
Results First Posted : August 2, 2016
Last Update Posted : March 31, 2017
Sponsor:
Collaborator:
Immune Control
Information provided by (Responsible Party):
Tufts Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: Fluphenazine
Drug: Placebo
Enrollment 15
Recruitment Details Recruitment from a dermatology clinic of a tertiary care medical center. Recruitment dates from Oct 2008 to Sep 2010.
Pre-assignment Details  
Arm/Group Title All Study Participants
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title All Study Participants - Fluphenazine
Hide Arm/Group Description 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 Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  93.3%
>=65 years
1
   6.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
51.5  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
3
  20.0%
Male
12
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Change in Target Lesion Scoring Evaluated at Baseline and 4 Weeks
Hide Description 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.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who successfully were enrolled.
Arm/Group Title Placebo Fluphenazine
Hide Arm/Group Description:
The sterile placebo: Bacteriostatic Sodium Chloride for Injection.
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 Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.4  (1.5) -1.4  (1.8)
2.Secondary Outcome
Title Change in the Target Lesion Visual Analog Scale (VAS) Score for Pruritus Evaluated at Baseline and 4 Weeks
Hide Description 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.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed entire trial.
Arm/Group Title Placebo Fluphenazine
Hide Arm/Group Description:
The sterile placebo: Bacteriostatic Sodium Chloride for Injection.
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 Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: percentage of baseline pruritus
0.86  (15.0) -2.16  (22.9)
3.Secondary Outcome
Title Safety Outcome Measures
Hide Description adverse events will be recorded and monitored. Adverse events will be noted in a separate chart.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed enrollment.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
Participants who experienced at least one adverse event.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: All Study Participant
12
4.Secondary Outcome
Title Fluphenazine Serum Levels Measured at Baseline, 2 Hours Post Dose and 1 Week Post Dose.
Hide Description Number of participants with fluphenazine serum levels > 0.200ng/ml, at baseline, 2 hours post dose and 1 week post dose.
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were enrolled and completed baseline and week 1 were included.
Arm/Group Title Baseline 2 Hours Post Dose 1 Week Post Dose
Hide Arm/Group Description:
Number of participants with fluphenazine serum levels > 0.200ng/ml at baseline
Number of participants with fluphenazine serum levels > 0.200ng/ml, 2 hours after administration
Participants with fluphenazine serum levels > 0.200ng/ml
Overall Number of Participants Analyzed 15 15 15
Measure Type: Number
Unit of Measure: participants
0 2 2
Time Frame 1 year, 10 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Study Participants
Hide Arm/Group Description 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
All-Cause Mortality
All Study Participants
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Study Participants
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Study Participants
Affected / at Risk (%) # Events
Total   12/15 (80.00%)    
Eye disorders   
Dry Eyes *  1/15 (6.67%)  1
Gastrointestinal disorders   
Nausea *  2/15 (13.33%)  2
Vomiting *  2/15 (13.33%)  2
General disorders   
Difficulty Sleeping *  2/15 (13.33%)  2
Fatigue *  2/15 (13.33%)  2
Dry mouth *  1/15 (6.67%)  1
Unusual dreams *  2/15 (13.33%)  2
Injury, poisoning and procedural complications   
Abrasion *  1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders   
Sprained Medial Collateral Ligament *  1/15 (6.67%)  1
Gout *  1/15 (6.67%)  1
Ankle Pain *  1/15 (6.67%)  1
Psychiatric disorders   
Nightmares *  1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders   
Upper Respiratory Infection * [1]  2/15 (13.33%)  2
Skin and subcutaneous tissue disorders   
Xerosis *  1/15 (6.67%)  1
Injection Site Pain *  2/15 (13.33%)  2
Nighttime Sweats *  1/15 (6.67%)  1
Bruise, Upper left arm *  1/15 (6.67%)  1
Blisters *  1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Self limited Upper Respiratory Infection
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
Layout table for Results Point of Contact information
Name/Title: Alice Gottlieb, MD PhD
Organization: Tufts Medical Center
Phone: 617-636-7462
EMail: agottlieb@tuftsmedicalcenter.org
Layout table for additonal information
Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00929578     History of Changes
Other Study ID Numbers: FP-CL2
First Submitted: June 25, 2009
First Posted: June 29, 2009
Results First Submitted: August 13, 2012
Results First Posted: August 2, 2016
Last Update Posted: March 31, 2017