Photodynamic Therapy for Oral Precursor Lesions

Leukoplakia Clinical Trial

— PDT  

Official title:

A Randomized Controlled Trial: Photodynamic Treatment for the Therapy of Premalignant Mucosal Oral Lesions.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497951
• Other study ID #: 2010_MuSH
• Status: Completed
• Phase: Phase 3
• First received: December 9, 2011
• Last updated: May 16, 2017
• Start date: May 2011
• Est. completion date: January 2017

Study information

• Verified date: May 2017
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pre-malignant lesions are difficult to treat. Even after surgical removal they tend to re-appear. Often the lesions are to large and are apparent on many sites, therefore surgical removal is not always possible. The photodynamic therapy uses a special substance, which is absorbed in cells, and thereafter activated by a defined light. The aim of this study is to compare the photodynamic therapy in potentially malignant lesions to a placebo. The investigators assume a significant better result in photodynamic therapy then treatment with a placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukoplakia
• Lichen

Intervention

Other:
• Aminolaevulinic acid
Photodynamic therapy
• Methylcellulose Placebo
Methylcellulose

Locations

Country	Name	City	State
Austria	Bernhard Gottlieb University Clinic of Dentistry	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in percent (%) of the initial area in mm2 assessed on recall appointment and by a blinded examiner on photographs with a caliper.		each treatment average once a week, recall after 4 weeks
Secondary	pain due to treatment, assessed by visual analogue scale (VAS)		each treatment, average once a week