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Completed

NCT Number: NCT01497951

Photodynamic Therapy for Oral Precursor Lesions

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.

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Key information

Conditions

Leukoplakia Lichen Neoplasms Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bernhard Gottlieb University Clinic of Dentistry

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aminolaevulinic acid

Other

Photodynamic therapy

Methylcellulose Placebo

Other

Methylcellulose

Primary outcomes

  1. Changes in percent (%) of the initial area in mm2 assessed on recall appointment and by a blinded examiner on photographs with a caliper.

    Time frame: each treatment average once a week, recall after 4 weeks

Secondary outcomes

  1. pain due to treatment, assessed by visual analogue scale (VAS)

    Time frame: each treatment, average once a week

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Acronym: PDT

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Dec 23, 2011
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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