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Fluphenazine Decanoate for Psoriasis

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ClinicalTrials.gov Identifier: NCT00356200
Recruitment Status : Terminated (Enrollment criteria met)
First Posted : July 25, 2006
Results First Posted : December 22, 2010
Last Update Posted : December 22, 2010
Sponsor:
Collaborator:
Immune Control
Information provided by:
Tufts Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: Fluphenazine Decanoate
Drug: Placebo
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1: 10 ug/ml Fluphenazine Decanoate Cohort 2: 100 ug/ml Fluphenazine Decanoate
Hide Arm/Group Description 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. 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.
Period Title: Cohort 1: 10 ug/ml
Started 5 0
Completed 4 0
Not Completed 1 0
Reason Not Completed
Lack of Efficacy             1             0
Period Title: Cohort 2: 100 ug/ml (New Patients)
Started 0 5
Completed 0 3
Not Completed 0 2
Reason Not Completed
Lack of Efficacy             0             2
Arm/Group Title Cohort 1: 10 ug/ml Fluphenazine Decanoate Cohort 2: 100 ug/ml Fluphenazine Decanoate Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
5
 100.0%
10
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 10 participants
41.6  (11.70) 38.8  (6.69) 39.1  (8.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
1
  20.0%
2
  40.0%
3
  30.0%
Male
4
  80.0%
3
  60.0%
7
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 5 participants 10 participants
5 5 10
1.Primary Outcome
Title Change in Target Lesion Score at Week 4 Compared to Baseline
Hide Description 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).
Time Frame Baseline to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
all 5 patients per cohort completed the visit at week 4
Arm/Group Title Cohort 1, 10 ug/ml Fluphenazine Treated Lesion Cohort 1, Placebo Treated Lesion Cohort 2, 100 ug/ml Fluphenazine Treated Lesion Cohort 2, Placebo Treated Lesion
Hide Arm/Group Description:
Cohort 1 10 ug/ml Fluphenazine decanoate treated lesion
Cohort 1 lesion treated with placebo
Cohort 2 100 ug/ml Fluphenazine decanoate treated lesion
Cohort 2 lesion treated with placebo
Overall Number of Participants Analyzed 5 5 5 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1  (2.45) -0.8  (2.68) -0.4  (2.19) -1.5  (2.40)
2.Secondary Outcome
Title Change in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 4 Compared to Baseline.
Hide Description 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).
Time Frame Baseline to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
all 5 patients per cohort completed the visit at week 4
Arm/Group Title Cohort 1, 10 ug/ml Fluphenazine Treated Lesion Cohort 1, Placebo Treated Lesion Cohort 2, 100 ug/ml Fluphenazine Treated Lesion Cohort 2, Placebo Treated Lesion
Hide Arm/Group Description:
lesion receiving 10 ug/ml Fluphenazine decanoate (Cohort 1)
lesion treated with placebo (Cohort 1)
lesion receiving 100 ug/ml Fluphenazine decanoate (Cohort 2)
lesion treated with placebo (Cohort 2)
Overall Number of Participants Analyzed 5 5 5 5
Mean (Standard Deviation)
Unit of Measure: mm
-30  (35.07) -27.2  (34.69) -18  (34.87) -32.6  (31.81)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1: 10 ug/ml Fluphenazine Decanoate Cohort 2: 100 ug/ml Fluphenazine Decanoate
Hide Arm/Group Description 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 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
All-Cause Mortality
Cohort 1: 10 ug/ml Fluphenazine Decanoate Cohort 2: 100 ug/ml Fluphenazine Decanoate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: 10 ug/ml Fluphenazine Decanoate Cohort 2: 100 ug/ml Fluphenazine Decanoate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Cohort 1: 10 ug/ml Fluphenazine Decanoate Cohort 2: 100 ug/ml Fluphenazine Decanoate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/5 (80.00%)      4/5 (80.00%)    
Eye disorders     
contact lens irritation   0/5 (0.00%)  0 1/5 (20.00%)  1
Infections and infestations     
cold/sinus symptoms   2/5 (40.00%)  2 1/5 (20.00%)  1
cough   0/5 (0.00%)  0 1/5 (20.00%)  1
upper respiratory tract infection   0/5 (0.00%)  0 1/5 (20.00%)  1
Injury, poisoning and procedural complications     
injection site pain * [1]  1/5 (20.00%)  1 0/5 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back Pain   1/5 (20.00%)  1 0/5 (0.00%)  0
Nervous system disorders     
dizziness   1/5 (20.00%)  1 0/5 (0.00%)  0
Headache   1/5 (20.00%)  1 0/5 (0.00%)  0
migraine   0/5 (0.00%)  0 1/5 (20.00%)  1
tired   0/5 (0.00%)  0 1/5 (20.00%)  1
Renal and urinary disorders     
Hematuria   0/5 (0.00%)  0 1/5 (20.00%)  1
Skin and subcutaneous tissue disorders     
contact dermatitis   0/5 (0.00%)  0 1/5 (20.00%)  1
itchy lesions * [2]  2/5 (40.00%)  2 1/5 (20.00%)  1
lesion pain * [3]  1/5 (20.00%)  1 0/5 (0.00%)  0
pruritis   0/5 (0.00%)  0 1/5 (20.00%)  1
psoriatic lesion spreading * [4]  1/5 (20.00%)  1 0/5 (0.00%)  0
sunburn (1st degree) * [5]  0/5 (0.00%)  0 1/5 (20.00%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
local reaction, occurred in both fluphenazine treated and placebo treated lesions
[2]
local reaction. In both cohort 1 patients, occurred in both fluphenazine treated and placebo treated lesions. In the cohort 2 patient, occurred in only fluphenazine treated lesion.
[3]
local reaction, occurred in only fluphenazine treated lesion
[4]
local reaction, occurred in both fluphenazine treated and placebo treated lesions in addition to other non target lesions.
[5]
local reaction
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 B Gottlieb, MD, PhD
Organization: Tufts Medical Center
Phone: 617 636 4802
EMail: agottlieb@tuftsmedicalcenter.org
Layout table for additonal information
Responsible Party: Alice B Gottlieb, MD, PhD, Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00356200     History of Changes
Other Study ID Numbers: FP-CL1
First Submitted: July 24, 2006
First Posted: July 25, 2006
Results First Submitted: November 15, 2010
Results First Posted: December 22, 2010
Last Update Posted: December 22, 2010