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

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.

Timeline

Start

2004-04

Primary completion

2004-12

Completion

2004-12

Publications

• Background 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.

Drugs

Indications