Safety and Effectiveness of Efalizumab to Treat 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single Center, Open-label, Pilot Study Evaluating the Safety and Effectiveness of Subcutaneous Efalizumab in the Treatment of Oral Lichen Planus|
- primary efficacy measure will be oral mucosal surface area involvement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
- clinical lesion score [ Time Frame: Week 0, 1, 4, 8, 12, and 20 ] [ Designated as safety issue: No ]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
- ten centimeter visual analogue pain scale [ Time Frame: Week 0, 1, 4, 8, 12, and 20 ] [ Designated as safety issue: No ]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
- oral health impact profile-14 questionnaire [ Time Frame: Week 0, 1, 4, 8, 12, and 20 ] [ Designated as safety issue: No ]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.
- cutaneous surface area involvement [ Time Frame: Week 0, 1, 4, 8, 12, and 20 ] [ Designated as safety issue: No ]The area of cutaneous disease involvement was measured in cm2
|Study Start Date:||January 2005|
|Study Completion Date:||November 2005|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Michael P. Heffernan, MD||Washington University School of Medicine|