| Methods |
Randomised controlled, double‐blind
Parallel assignment
Location: University of Tennessee Health Science Center, Memphis, Tennessee, USA |
| Participants |
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 form 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 moisturisers
Exclusion Criteria:
Pustular forms of psoriasis, either localised or generalised Generalised 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
|
| Interventions |
Bicillin L‐A administered intramuscularly in a dose of 2.4 million units every three weeks versus placebo
The duration of intervention administration was not indicated |
| Outcomes |
A reduction of an individual's PASI by 75% after five 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)
No more precision on outcome time points |
| Notes |
Unpublished trial:
It was stated in 'recruitment status' that the trial was terminated (not enough enrollees to obtain a valid conclusion) on 21 April 2015 |
