Clobetasol propionate 0.05% versus placebo for the management of erosive oral lichen planus
- Conditions
- Oral lichen planusSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN10647973
- Lead Sponsor
- niversity of Turin (Italy)
- Brief Summary
2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29297958
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
1. Histological diagnosis of OLP on the basis of WHO criteria: hyperkeratosis of the superficial epithelial layers, vacuolar degeneration of the germinative layer of the epithelium and band-like sub-epithelial lymphocytic inflammatory infiltrate
2. Presence of painful and atrophic-erosive oral lesions, at the same time with reticular ones
3. Ability to complete the present trial
1. Presence of histological signs of dysplasia
2. Use of lichenoid reaction inducing drugs and presence of amalgam fillings close to lesions
3. Therapy for OLP in the 2 months prior to the study
4. Pregnant or breastfeeding women
5. Proved or suspected hypersensitivity caused by the tested chemicals
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain (visual analogue scale [VAS]) and clinical scores (Thongpranson scale) assessed at baseline, 4 weeks, 8 weeks, 20 weeks and 32 weeks
- Secondary Outcome Measures
Name Time Method 1. Time taken to reduce signs and symptoms during the first two weeks of treatment<br>2. Length of remission from signs and symptoms