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

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Tennessee
• Treatments: Penicillin G; Penicillin G Benzathine; Penicillin G Procaine

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