Fluphenazine Decanoate for Psoriasis

This study has been terminated.

( Enrollment criteria met )

Study NCT00356200 Information provided by Tufts Medical Center

First Received on July 24, 2006. Last Updated on December 20, 2010 History of Changes

Results First Received: November 15, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Psoriasis
Interventions:	Drug: Fluphenazine Decanoate Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.

Participant Flow for 2 periods

Period 1: Cohort 1: 10 ug/ml

	Cohort 1: 10 ug/ml Fluphenazine Decanoate	Cohort 2: 100 ug/ml Fluphenazine Decanoate
STARTED	5	0
COMPLETED	4	0
NOT COMPLETED	1	0
Lack of Efficacy	1	0

Period 2: Cohort 2: 100 ug/ml (New Patients)

	Cohort 1: 10 ug/ml Fluphenazine Decanoate	Cohort 2: 100 ug/ml Fluphenazine Decanoate
STARTED	0	5
COMPLETED	0	3
NOT COMPLETED	0	2
Lack of Efficacy	0	2

Baseline Characteristics

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Reporting Groups

	Description
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

Baseline Measures

	Cohort 1: 10 ug/ml Fluphenazine Decanoate	Cohort 2: 100 ug/ml Fluphenazine Decanoate	Total
Number of Participants [units: participants]	5	5	10
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	5	5	10
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	41.6 ± 11.70	38.8 ± 6.69	39.1 ± 8.99
Gender [units: participants]
Female	1	2	3
Male	4	3	7
Region of Enrollment [units: participants]
United States	5	5	10

Outcome Measures

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1. Primary:

Change in Target Lesion Score at Week 4 Compared to Baseline [ Time Frame: Baseline to week 4 ]

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2. Secondary:

Change in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 4 Compared to Baseline. [ Time Frame: Baseline to week 4 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Alice B Gottlieb, MD, PhD
Organization: Tufts Medical Center
phone: 617 636 4802
e-mail: agottlieb@tuftsmedicalcenter.org

Publications:

Tutrone WD, Kagen MH, Barbagallo J, Weinberg JM. Biologic therapy for psoriasis: a brief history, II. Cutis. 2001 Dec;68(6):367-72. Review.

Kipnis CD, Myers WA, Opeola M, Gottlieb AB. Biologic treatments for psoriasis. J Am Acad Dermatol. 2005 Apr;52(4):671-82. No abstract available.

Gupta MA, Gupta AK. Psychiatric and psychological co-morbidity in patients with dermatologic disorders: epidemiology and management. Am J Clin Dermatol. 2003;4(12):833-42. Review.

Gupta MA, Guptat AK. The use of antidepressant drugs in dermatology. J Eur Acad Dermatol Venereol. 2001 Nov;15(6):512-8. Review.

Responsible Party:	Alice B Gottlieb, MD, PhD, Tufts Medical Center
ClinicalTrials.gov Identifier:	NCT00356200 History of Changes
Other Study ID Numbers:	FP-CL1
Study First Received:	July 24, 2006
Results First Received:	November 15, 2010
Last Updated:	December 20, 2010
Health Authority:	United States: Food and Drug Administration