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

University of Tennessee

Status and phase

Terminated

Phase 2

Conditions

Psoriasis

Treatments

Drug: Bicillin L-A

Study type

Interventional

Funder types

Other

Identifiers

NCT00427609

8389

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts 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