Role and efficacy of topical 5-Aminolevulinic Acid (5-ALA) in Photodynamic detection (PDD) in determining malignant potential of oral lichen planus - PDD for Oral Lichen Planus
Phase 1
- Conditions
- Oral Lichen PlanusMedDRA version: 8.1Level: LLTClassification code 10030983Term: Oral lichen planus
- Registration Number
- EUCTR2006-004760-31-GB
- Lead Sponsor
- niversity of Dundee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Willingness to participate Oral Lesions including oral malignant disease affecting the mouth lining Able to use mouthwash for 15 minutes Able to comply with instructions Woman of child bearing age who are not pregnant Age 18-75 years Signed and dated consent form prior to application
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Patients with obvious non-oral malignant disease Those unable to give informed consent Pregnant woman Patients with porphyria
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assist diagnosis of Oral Lichen planus non invasively so that surgical biopsy is not required by studying the characteristics of 5 aminolevulinic acid (ALA) induced protoporphyrin IX (PpIX) fluorescence in oral lesions.;Secondary Objective: To illuminate the borders of the lesion and establish if non malignant lesions give different readings of PpIX;Primary end point(s): Distinguish between Oral Lichen Planus and early stage cancer by detecting peaks in PpIX fluorescence
- Secondary Outcome Measures
Name Time Method