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Bicillin L-A vs Placebo for the Treatment of Chronic, Plaque-Type Psoriasis Unresponsive to Topical Medications

Primary Purpose

Psoriasis

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Bicillin L-A

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Treatment, Psoriasis, efficacy, Bicillin

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male or female between 18 and 50 years of age (with onset before age 40)
Presence of chronic plaque type psoriasis unresponsive to treatment with topical preparations and extensive enough to consider appropriateness of systemic therapy
Guttate forms of psoriasis
Non-responsive to treatment or worsening of the pre-existing psoriasis
With the exception of their skin disease , in good general state of health based on a complete medical history, blood test and urine analysis.
Females must have negative urine pregnancy test and willing to take additional measures to keep from becoming pregnant during the course of the study
No systemic prescription medication to control psoriasis within past 30 days
Free of any topical antipsoriatic preparation for the duration of the study with the exception of emollients and moisturizers

Exclusion Criteria:

Pustular forms of psoriasis, either localized or generalized
Generalized Erythrodermic psoriasis
Only palmoplantar psoriasis
Only scalp psoriasis
Only nail psoriasis
Only inverse psoriasis
Diabetes or impaired glucose tolerance
History of recurrent yeast infections
History of hypersensitivity to Penicillin
History of severe adverse drug reactions
Pregnancy
Lactation
HIV/AIDS
History of renal disease
History of liver disease
History or presence of alcohol and/or drug dependence or abuse
History of significant psychiatric illness
History of allergy, asthma, allergic rhinitis, or urticaria subjects in other research trials, at least 30 days prior to the beginning of this study

Sites / Locations

University of Tennessee Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

A reduction of an individual's PASI by 75% after five (5) treatments of the active drug (Bicillin L-A). To demonstrate benefit comparable to the currently available biologicals, the response rate of Bicillin L-A must be at least 40%

Secondary Outcome Measures

Full Information

NCT ID

NCT00427609

First Posted

January 25, 2007

Last Updated

April 20, 2015

Sponsor

University of Tennessee

1. Study Identification

Unique Protocol Identification Number

NCT00427609

Brief Title

Bicillin L-A vs Placebo for the Treatment of Chronic, Plaque-Type Psoriasis Unresponsive to Topical Medications

Official Title

Efficacy of Bicillin LA for the Treatment of Chronic, Plaque-type Psoriasis Unresponsive to Topical Medications.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Terminated

Why Stopped

Not enough enrollees to obtain a valid conclusion

Study Start Date

January 2007 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Tennessee

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine the efficacy for Bicillin L-A, administered intramuscularly in a dose of 2.4 million units every three (3) weeks, for the treatment of chronic, plaque-type psoriasis unresponsive to topical medications or when other systemic therapies are contraindicated.

Detailed Description

Psoriasis is a chronic, inflammatory skin disorder most commonly manifested by well-demarcated, erythematous and/or scaling plaques on the elbows, knees, scalp, and trunk. Psoriasis is a common disease with overall incidence of 1-3% of the general population. The estimated prevalence varies from 1-2%. There is significant geographical variability with the lowest incidence of the disease around the equator and increasing towards the poles. Psoriasis is now considered an autoimmune disease mediated by activated T-cells, releasing proinflammatory cytokines, predominately TNF-a and IFN-y. The key role for T-cells in the pathogenesis of psoriasis was supported by reported beneficial effects of specific T cell targeted therapies including cyclosporin A and certain recently marketed immune response modifiers. While disease pathogenesis is still not completely understood, the factors that may trigger or worsen psoriasis have been systematically studied and well described in the medical literature. Psychological stress, mechanical trauma to the skin, certain medications and Streptococcus strains are the most common disease triggers. It was first reported in 1916 that the onset of psoriasis is often preceded by throat infections with hemolytic streptococci and the role of M-protein positive beta hemolytic streptococci in triggering guttate psoriasis has been confirmed in subsequent studies. Exacerbation of chronic plaque type psoriasis has been reported in association with tonsillitis in retrospective studies. Moreover, high frequency of remission after tonsillectomy or antibiotic treatment has been documented.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

Treatment, Psoriasis, efficacy, Bicillin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Bicillin L-A

Intervention Description

Bicillin L-A administered intramusculary in a dose of 2.4 million units every three weeks or normal saline injection administered intramusculary in a dose of 3 cc every three weeks

Primary Outcome Measure Information:

Title

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female between 18 and 50 years of age (with onset before age 40) Presence of chronic plaque type psoriasis unresponsive to treatment with topical preparations and extensive enough to consider appropriateness of systemic therapy Guttate forms of psoriasis Non-responsive to treatment or worsening of the pre-existing psoriasis With the exception of their skin disease , in good general state of health based on a complete medical history, blood test and urine analysis. Females must have negative urine pregnancy test and willing to take additional measures to keep from becoming pregnant during the course of the study No systemic prescription medication to control psoriasis within past 30 days Free of any topical antipsoriatic preparation for the duration of the study with the exception of emollients and moisturizers Exclusion Criteria: Pustular forms of psoriasis, either localized or generalized Generalized Erythrodermic psoriasis Only palmoplantar psoriasis Only scalp psoriasis Only nail psoriasis Only inverse psoriasis Diabetes or impaired glucose tolerance History of recurrent yeast infections History of hypersensitivity to Penicillin History of severe adverse drug reactions Pregnancy Lactation HIV/AIDS History of renal disease History of liver disease History or presence of alcohol and/or drug dependence or abuse History of significant psychiatric illness History of allergy, asthma, allergic rhinitis, or urticaria subjects in other research trials, at least 30 days prior to the beginning of this study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elias Rosenberg, MD

Organizational Affiliation

University of Tennessee

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Tennessee Health Science Center

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38163

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Bicillin L-A vs Placebo for the Treatment of Chronic, Plaque-Type Psoriasis Unresponsive to Topical Medications

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