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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Washington University
St Louis, Missouri, United States
primary efficacy measure will be oral mucosal surface area involvement
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.
Time frame: 12 weeks
clinical lesion score
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
Time frame: Week 0, 1, 4, 8, 12, and 20
ten centimeter visual analogue pain scale
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
Time frame: Week 0, 1, 4, 8, 12, and 20
oral health impact profile-14 questionnaire
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.
Time frame: Week 0, 1, 4, 8, 12, and 20
cutaneous surface area involvement
The area of cutaneous disease involvement was measured in cm2
Time frame: Week 0, 1, 4, 8, 12, and 20
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