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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00427609
Recruitment Status : Terminated (Not enough enrollees to obtain a valid conclusion)
First Posted : January 29, 2007
Last Update Posted : April 21, 2015
Information provided by (Responsible Party):
University of Tennessee

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Bicillin L-A Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Bicillin LA for the Treatment of Chronic, Plaque-type Psoriasis Unresponsive to Topical Medications.
Study Start Date : January 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Arm Intervention/treatment
Placebo Comparator: 1 Drug: Bicillin L-A
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
Active Comparator: 2 Drug: Bicillin L-A
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 Measures :
  1. 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% [ Time Frame: One year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00427609

United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
University of Tennessee
Principal Investigator: Elias Rosenberg, MD University of Tennessee Health Science Center

Responsible Party: University of Tennessee Identifier: NCT00427609     History of Changes
Other Study ID Numbers: 8389
First Posted: January 29, 2007    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015

Keywords provided by University of Tennessee:

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Penicillin G Benzathine
Penicillin G
Penicillin G Procaine
Anti-Bacterial Agents
Anti-Infective Agents