A Safety and Efficacy Study of Alefacept in the Treatment of Moderate to Severe Erosive Mucosal Lichen Planus - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborators:	Brigham and Women's Hospital Stanford University Biogen Idec
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00135733

Purpose

The purpose of this study is to find out how safe and effective an investigational drug called alefacept (amevive) is for the treatment of moderate to severe erosive mucosal lichen planus.

Lichen planus is a skin disease that can last a long time and cause significant pain, itching, and scarring. It can affect the mucous membranes (area inside the mouth and vagina) and these areas can become erosive (sores can develop). Currently there is no known cure for this disease.

An investigational drug is one that has not been approved by the United States (US) Food and Drug Administration (FDA) to treat a particular condition or disease. Alefacept has been approved to treat psoriasis (a scaly skin rash). A number of reports suggest that lichen planus develops for some of the same reasons as psoriasis, but alefacept is not yet approved for the treatment of psoriasis.

Condition	Intervention	Phase
Lichen Planus	Drug: Amevive (Alefacept) Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Pilot Study of the Efficacy and Safety of Alefacept in the Treatment of Moderate to Severe Erosive Mucosal Lichen Planus

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Alefacept

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Statistically significant changes in pain level
Statistically significant changes in appearance of lesions (sores)

Secondary Outcome Measures:

Statistically significant changes in severity of itching
Statistically significant changes in redness, amount of body surface area involved, number of sores, and or depth of involvement
Statistically significant changes in quality of life

Enrollment:	13
Study Start Date:	April 2004
Study Completion Date:	December 2004
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A Amevive	Drug: Amevive (Alefacept)
Placebo Comparator: B Placebo	Drug: Placebo

Detailed Description:

Lichen planus is an inflammatory disorder that affects skin, mucous membranes (the skin in the mouth and vagina), nails, and hair. It is thought that T-cells (cells that help fight infection) become activated and multiply faster than normal and that this contributes to the development of the skin sores.

Alefacept works by slowing the rate at which T-cells become activated and helps to decrease the number of T-cells. By blocking the activity and decreasing the number of T-cells Alefacept may help improve the disease and decrease the sores on the skin.

Participants in this study will be randomly assigned to receive either alefacept or a placebo. A placebo looks just like the study drug but contains no active medication. Placebos help study doctors find out if the effects of the study drug are due to the drug itself or just because of being in the study. This type of study design helps measure the true effectiveness of a treatment. Participants have a 1 out of 2 chance of receiving alefacept and a 1 out of 2 chance of receiving placebo. Neither participants nor the study doctors will know which group participants have been assigned to.

The researchers expect to enroll 26 subjects in this study at research sites in the U.S. About 16 subjects will be enrolled at Brigham and Women's Hospital and Massachusetts General Hospital.

Biogen Idec., Inc. is the maker of alefacept and is the sponsor of this study.

If taking part in another research study or have taken part in a research study in the last 28 days, individuals will not be able to take part in this study. Patients cannot be on multiple studies simultaneously; however, exceptions are made for non-invasive, non-interventional, and observational studies.

This study will last 24 weeks, with a total of 16 visits; screening week 0 (baseline), weeks 1-12, week 16 and week 24. Participants will not be allowed to use any oral or injectable medications for lichen planus during this study. Participants also will not be allowed to use certain creams for lichen planus during the study. The study consists of weekly injections of the medication for 12 weeks and then a 12 week follow up period.

All participants must be at least 18 years of age with a diagnosis of moderate to severe mucosal lichen planus. Neither pregnant nor nursing women will be included in the study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Key Inclusion Criteria:

Written informed consent, authorize release and use of protected health information
At least 18 years of age
Diagnosis of moderate to severe mucosal lichen planus
No systemic (oral or injectable) treatment of lichen planus for 4 weeks prior to starting study drug.
Willing to forgo changes in topical treatment (creams) for 4 weeks before receiving the study drug and during the course of the study.
Off of topical tacrolimus or pimecrolimus for 4 weeks prior to starting the study drug
CD4+ T lymphocyte counts must be above the lower limit of normal laboratory value

Key Exclusion Criteria:

Clinically significant abnormal laboratory values
Skin lesions currently undiagnosed, but suspicious for malignancy
Other skin disease that might interfere with lichen planus status assessments.
History of malignancy other than basal cell carcinomas or fewer than 3 squamous cell carcinomas
Exposure to systemic therapy for lichen planus within 4 weeks prior to enrollment.
Previous exposure to alefacept

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135733

Locations

United States, Massachusetts
Clinical Unit for Research Trials in Skin
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Massachusetts General Hospital

Brigham and Women's Hospital

Stanford University

Biogen Idec

Investigators

Principal Investigator:

Alexandra B. Kimball, MD, MPH

CURTIS - Clinical Unit for Research Trials in Skin at Partners (MGH and BWH)

More Information

Additional Information:

CURTIS website This link exits the ClinicalTrials.gov site

Publications:

Daoud MS, Pittelkow MR, Fitzpatrick's Dermatology in General Medicine, sixth edition, ed. Freedberg IM, Eisen AZ, Wolff K, Austen KF, Goldsmith LA, Katz SI, McGraw-Hill, pp 463-476, 2003.

Responsible Party:	Alexandra Kimball, MD, MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00135733 History of Changes
Other Study ID Numbers:	2004P002141
Study First Received:	August 24, 2005
Last Updated:	February 10, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

Lichen Planus
Mucosal lichen planus
Alefacept

T-cell mediated
subcutaneous medication
Autoimmune disease

Additional relevant MeSH terms:

Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases

Alefacept
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012