Clinical Trial: Safety and Effectiveness of Efalizumab to Treat Oral Lichen Planus
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Single Center, Open-label, Pilot Study Evaluating the Safety and Effectiveness of Subcutaneous Efalizumab in the Treatment of Oral Lichen Planus
Brief 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.
Detailed Summary:
Sponsor: Washington University School of Medicine
Current Primary Outcome: primary efficacy measure will be oral mucosal surface area involvement [ Time Frame: 12 weeks ]
Original Primary Outcome: primary efficacy measure will be oral mucosal surface area involvement
Current Secondary Outcome:
- clinical lesion score [ Time Frame: Week 0, 1, 4, 8, 12, and 20 ]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 ]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 ]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 ]The area of cutaneous disease involvement was measured in cm2
Original Secondary Outcome:
- clinical lesion score
- ten centimeter visual analogue pain scale
- oral health impact profile-14 questionnaire
- cutaneous surface area involvement
Information By: Washington University School of Medicine
Dates:
Date Received: August 19, 2005
Date Started: January 2005
Date Completion:
Last Updated: August 18, 2011
Last Verified: August 2011