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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01497951
Other study ID # 2010_MuSH
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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