Photodynamic Therapy for Oral Precursor Lesions (PDT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01497951
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : May 17, 2017
Information provided by (Responsible Party):
Dvorak Gabriella, Medical University of Vienna

December 9, 2011
December 23, 2011
May 17, 2017
May 2011
January 2017   (Final data collection date for primary 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. [ Time Frame: each treatment average once a week, recall after 4 weeks ]
Same as current
Complete list of historical versions of study NCT01497951 on Archive Site
pain due to treatment, assessed by visual analogue scale (VAS) [ Time Frame: each treatment, average once a week ]
Same as current
Not Provided
Not Provided
Photodynamic Therapy for Oral Precursor Lesions
A Randomized Controlled Trial: Photodynamic Treatment for the Therapy of Premalignant Mucosal Oral 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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
  • Leukoplakia
  • Lichen
  • Other: Aminolaevulinic acid
    Photodynamic therapy
  • Other: Methylcellulose Placebo
  • Experimental: Aminolaevulinic acid
    Intervention: Other: Aminolaevulinic acid
  • Placebo Comparator: Placebo
    Intervention: Other: Methylcellulose Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2017
January 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Dvorak Gabriella, Medical University of Vienna
Medical University of Vienna
Not Provided
Study Director: Gabriella Dvorak, PD, DMD, MD Medical University Vienna
Medical University of Vienna
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP