A Randomized Controlled Trial: Photodynamic Treatment for the Therapy of Premalignant Mucosal Oral Lesions.
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Leukoplakia, Lichen
Both
Leukoplakia, Lichen
Trial Information
A Randomized Controlled Trial: Photodynamic Treatment for the Therapy of Premalignant Mucosal Oral Lesions.
Inclusion Criteria:
- Existing Leukoplakia simplex SIN III (diagnostics by Biopsie)
- Leukoplakia verrucosa without indications of malignant changes (diagnostics by
Biopsie)
- Oral Lichen planus SIN III (diagnostics by Biopsie)
- Good mouth hygiene status (tartar, surface)
- Correct seat of the prosthesis and/or the denture
- Located erosions in the oral cavity
- Minimum age:18 years
- Women at the age capable of child-bearing with an appropriate contraception
Exclusion Criteria:
- Malignant changes of the mucous membrane, heavy Dysplasie SIN III, Carcinoma in situ
- heavy vitamin deficiency
- Pregnancy
- less than 18
- Satisfying women
- No tobacco abuse
- satisfying therapy with local immunmodulators in lichen ruber
- surgical therapy of leukoplakia indicated
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Outcome Measure:
Changes in percent (%) of the initial area in mm2 assessed on recall appointment and by a blinded examiner on photographs with a caliper.
Outcome Time Frame:
each treatment average once a week, recall after 4 weeks
Safety Issue:
No
Principal Investigator
Georg Watzek, Prof.
Investigator Role:
Study Chair
Investigator Affiliation:
Medical University Vienna
Authority:
Austria: Ethikkommission
Study ID:
2010_MuSH
NCT ID:
NCT01497951
Start Date:
May 2011
Completion Date:
May 2012
Related Keywords:
- Leukoplakia
- Lichen
- Leukoplakia
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