PsoriasisPhase 2NCT00427609
Bicillin L-A vs Placebo for the Treatment of Chronic, Plaque-Type Psoriasis Unresponsive to Topical Medications
A Phase 2 study testing Bicillin L-A in people with Psoriasis, run by University of Tennessee at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Bicillin L-A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Nov 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Pustular forms of psoriasis, either localized or generalized
- Generalized Erythrodermic psoriasis
- Only palmoplantar psoriasis
- Only scalp psoriasis
- Only nail psoriasis
- Only inverse psoriasis
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
About this study
Official title: Efficacy of Bicillin LA for the Treatment of Chronic, Plaque-type Psoriasis Unresponsive to Topical Medications.
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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- Bicillin L-A
- Keywords
- Treatment, Psoriasis, efficacy, Bicillin
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bicillin L-ADrug
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Bicillin L-A |
| 2 | Active comparator | Not described Receives: Drug: Bicillin L-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Not enough enrollees to obtain a valid conclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elias Rosenberg, MD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427609
- Sponsor's protocol ID
- 8389
- Status last verified
- Apr 2015
- First submitted
- 25 Jan 2007
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bicillin LA for the Treatment of Chronic, Plaque-type Psoriasis Unresponsive to Topical Medications.
- ClinicalTrials.gov ID
- NCT00427609
- Acronym / sponsor ID
- 8389
- Conditions
- Psoriasis
- Keywords
- Treatment, Psoriasis, efficacy, Bicillin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough enrollees to obtain a valid conclusion
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 29 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Bicillin L-A |
| 2 | Active comparator | Drug: Bicillin L-A |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (18 listed)
- Pustular forms of psoriasis, either localized or generalized
- Generalized Erythrodermic psoriasis
- Only palmoplantar psoriasis
- Only scalp psoriasis
- Only nail psoriasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bicillin L-ABicillin 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 | Drug | 1, 2 |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Not enough enrollees to obtain a valid conclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elias Rosenberg, MD principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bicillin L-A in people with Psoriasis, run by University of Tennessee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Not enough enrollees to obtain a valid conclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2015.