NCT00135733

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
Last Updated

February 12, 2009

Status Verified

February 1, 2009

Enrollment Period

8 months

First QC Date

August 24, 2005

Last Update Submit

February 10, 2009

Conditions

Lichen Planus

Keywords

Lichen PlanusMucosal lichen planusAlefaceptT-cell mediatedsubcutaneous medicationAutoimmune disease

Outcome Measures

Primary Outcomes (2)

  • Statistically significant changes in pain level

  • Statistically significant changes in appearance of lesions (sores)

Secondary Outcomes (3)

  • 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

Study Arms (2)

A

ACTIVE COMPARATOR

Amevive

Drug: Amevive (Alefacept)

B

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Amevive (Alefacept)DRUG
A
PlaceboDRUG
B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Unit for Research Trials in Skin

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • 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.

    BACKGROUND

  • Stewart EG, Vulvar Lichen Planus, Up To Date, version 12.3, Aug 2004.

    BACKGROUND

MeSH Terms

Conditions

Lichen PlanusAutoimmune Diseases

Interventions

Alefacept

Condition Hierarchy (Ancestors)

Lichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CD58 AntigensMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesImmunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsMembrane ProteinsRecombinant Fusion ProteinsRecombinant Proteins

Study Officials

  • Alexandra B. Kimball, MD, MPH

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2005

First Posted

August 26, 2005

Study Start

April 1, 2004

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

February 12, 2009

Record last verified: 2009-02

Locations

US(1)