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

This study has been terminated.
(Not enough enrollees to obtain a valid conclusion)
Sponsor:
Information provided by:
University of Tennessee
ClinicalTrials.gov Identifier:
NCT00427609
First received: January 25, 2007
Last updated: February 23, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Psoriasis
Drug: Bicillin L-A
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Bicillin LA for the Treatment of Chronic, Plaque-type Psoriasis Unresponsive to Topical Medications.

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

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% [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2007
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427609

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

No publications provided

Responsible Party: Elias Rosenberg, MD, University of Tennessee
ClinicalTrials.gov Identifier: NCT00427609     History of Changes
Other Study ID Numbers: 8389
Study First Received: January 25, 2007
Last Updated: February 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
Treatment
Psoriasis
efficacy
Bicillin

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Penicillin G
Penicillin G Benzathine
Penicillin G Procaine
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014