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 ]

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.


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