Lichen Planus, OralNCT00133107
Safety and Effectiveness of Efalizumab to Treat Oral Lichen Planus
A study testing efalizumab in people with Lichen Planus, Oral, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study is to determine whether efalizumab 1.0mg/kg given by subcutaneous injection for 12 weeks is effective in treating oral lichen planus. This is a 20 week, single center, open-label pilot study to enroll 5 subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lichen Planus, Oral
- What is being tested?
- efalizumab
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Nov 2005
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent
- Subject able and willing to comply with study requirements for the full duration of the study.
- Age > 18 years.
- Subject has a diagnosis of oral lichen planus deemed by the investigator to be of sufficient severity to require systemic agents. The diagnosis can be made by biopsy proven oral lichen planus or biopsy proven cutaneous lichen planus in the setting of a subject with oral disease consistent with lichen planus.
- Subject has a clinical lesion score of at least 2.
- If female of childbearing potential, subject will have a negative urine pregnancy test at screening and week 0.
- If female, subject will be either post-menopausal for > 1 year; surgically sterile (hysterectomy or bilateral tubal ligation); or practicing one form of birth control (abstinence, oral contraceptive, estrogen patch, implant contraception, injectable contraception, intrauterine device [IUD], diaphragm, condom, sponge, spermicides, or vasectomy of partner). Female subjects will continue to use contraception for 3 months following the last injection.
- Subjects must be on stable doses of topical medications, such as corticosteroids, cyclosporine, and tacrolimus for the past 4 weeks.
Who cannot join
- Patients with known hypersensitivity to Raptiva (efalizumab) or any of its components.
- Pregnant or lactating women
- Subject has evidence of a clinically significant, unstable or poorly controlled medical condition.
- Subject has a chest X-ray consistent with an active infection or previous exposure to tuberculosis (TB) and/or a positive purified protein derivative test at screening (> 5 mm). (Subjects may participate if they are being actively treated in accordance with Centers for Disease Control [CDC] guidelines.)
- Subject has a serious, active or recurrent bacterial, viral, or fungal infection. This includes hepatitis B and C, and HIV.
- Subject has been hospitalized for infection or received intravenous (IV) antibiotics within the previous 2 months prior to baseline.
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- Subject has a history of tuberculosis without documented adequate therapy.
- Subject has been diagnosed with a malignancy within the past 5 years except for successfully treated non-melanoma skin cancer.
- Subject has any dermatologic disease in the target site that may be exacerbated by treatment or interfere with examination.
- Subject has been administered an investigational drug in another clinical study within 30 days prior to baseline (or 5 half-lives, whichever is longer). Subjects in observational studies without investigational drugs or devices may still be enrolled.
- Subject has used the following systemic agents within 4 weeks prior to week 0: photochemotherapy, systemic corticosteroids, cyclosporine, tacrolimus, azathioprine, methotrexate, mycophenolate mofetil, hydroxychloroquine, chloroquine, quinacrine, dapsone, or thalidomide.
- Subject has previously been treated with biologic immune response modifiers including alefacept, etanercept, infliximab, or adalimumab within 12 weeks prior to day 0 (or 5 half-lives, whichever is longer).
- Subject has previously been treated with efalizumab.
- Subject weighs over 125 kg.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Open-label, Pilot Study Evaluating the Safety and Effectiveness of Subcutaneous Efalizumab in the Treatment of Oral Lichen Planus
This study is to determine whether efalizumab 1.0mg/kg given by subcutaneous injection for 12 weeks is effective in treating oral lichen planus.
This is a 20 week, single center, open-label pilot study to enroll 5 subjects.
- Conditions
- Lichen Planus, Oral
- Being tested
- efalizumab
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efalizumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
primary efficacy measure will be oral mucosal surface area involvement
area of oral mucosa involvement was measured in cm2 at baseline, week 4, week 8, week 12 and week 20. the primary efficacy outcome measure was the change in oral mucosal involvement at week 12.
Measured: 12 weeks
Secondary outcomes (4)
clinical lesion score
a numerical score from 0 to 5 where 0 = no lesion; 1 = white striae only; 2 = white striae and erosion < 1 cm; 3 = white striae and erosion > 1 cm; 4 = white striae and ulceration < 1 cm; 5 = white striae and ulceration > 1 cm
Measured: Week 0, 1, 4, 8, 12, and 20
ten centimeter visual analogue pain scale
Patients were asked to put an X on a 10 cm line that corresponded to their degree of pain where 0 cm represented no pain and 10 cm represented the most severe pain
Measured: Week 0, 1, 4, 8, 12, and 20
oral health impact profile-14 questionnaire
The OHIP-14 is a validated measure of the negative impact of oral disease on an individual's well being. The impact of various oral problems are rated from "never" to "very often," which correlates to a score of 0 to 4. The responses are weighted and summated giving a maximum score of 56 and a minimum score of 0.
Measured: Week 0, 1, 4, 8, 12, and 20
cutaneous surface area involvement
The area of cutaneous disease involvement was measured in cm2
Measured: Week 0, 1, 4, 8, 12, and 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startJan 2005
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen Planus, OralStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Investigators
- Michael P. Heffernan, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133107
- Sponsor's protocol ID
- LP-efalizumab
- Status last verified
- Aug 2011
- First submitted
- 19 Aug 2005
- Last updated
- 19 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-label, Pilot Study Evaluating the Safety and Effectiveness of Subcutaneous Efalizumab in the Treatment of Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT00133107
- Acronym / sponsor ID
- LP-efalizumab
- Conditions
- Lichen Planus, Oral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jan 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 22 Aug 2005 (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.
This study is to determine whether efalizumab 1.0mg/kg given by subcutaneous injection for 12 weeks is effective in treating oral lichen planus.
This is a 20 week, single center, open-label pilot study to enroll 5 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to provide written informed consent
- Subject able and willing to comply with study requirements for the full duration of the study.
- Age > 18 years.
- Subject has a diagnosis of oral lichen planus deemed by the investigator to be of sufficient severity to require systemic agents. The diagnosis can be made by biopsy proven oral lichen planus or biopsy proven cutaneous lichen planus in the setting of a subject with oral disease consistent with lichen planus.
- Subject has a clinical lesion score of at least 2.
Key exclusion criteria (14 listed)
- Patients with known hypersensitivity to Raptiva (efalizumab) or any of its components.
- Pregnant or lactating women
- Subject has evidence of a clinically significant, unstable or poorly controlled medical condition.
- Subject has a chest X-ray consistent with an active infection or previous exposure to tuberculosis (TB) and/or a positive purified protein derivative test at screening (> 5 mm). (Subjects may participate if they are being actively treated in accordance with Centers for Disease Control [CDC] guidelines.)
- Subject has a serious, active or recurrent bacterial, viral, or fungal infection. This includes hepatitis B and C, and HIV.
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 |
|---|---|---|
| efalizumab | Drug | – |
Primary outcome
primary efficacy measure will be oral mucosal surface area involvement
Time frame: 12 weeks
area of oral mucosa involvement was measured in cm2 at baseline, week 4, week 8, week 12 and week 20. the primary efficacy outcome measure was the change in oral mucosal involvement at week 12.
4 secondary outcomes
clinical lesion score
Time frame: Week 0, 1, 4, 8, 12, and 20
ten centimeter visual analogue pain scale
Time frame: Week 0, 1, 4, 8, 12, and 20
oral health impact profile-14 questionnaire
Time frame: Week 0, 1, 4, 8, 12, and 20
cutaneous surface area involvement
Time frame: Week 0, 1, 4, 8, 12, and 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2011.
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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.
Michael P. Heffernan, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing efalizumab in people with Lichen Planus, Oral, run by Washington University School of Medicine 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 14 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: finished, as of the sponsor's last update on 19 Aug 2011. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
primary efficacy measure will be oral mucosal surface area involvement (time frame: 12 weeks). 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 19 Aug 2011.