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

NCT00427609 | Terminated Phase 2

• 1 other identifier: 8389
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Treatment; Psoriasis; efficacy; Bicillin

Outcome Measures

Primary Outcomes (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%

  One year

Study Arms (2)

1

PLACEBO COMPARATOR

Drug: Bicillin L-A

2

ACTIVE COMPARATOR

Drug: Bicillin L-A

Interventions

Bicillin L-A DRUG

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

1; 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Penicillin G Benzathine

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Elias Rosenberg, MD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: January 29, 2007
• Study Start: January 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 21, 2015

Record last verified: 2015-04

Locations

US (1)