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Photodynamic Therapy for Oral Precursor Lesions (PDT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dvorak Gabriella, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01497951
First received: December 9, 2011
Last updated: May 16, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention Phase
Leukoplakia Lichen Other: Aminolaevulinic acid Other: Methylcellulose Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial: Photodynamic Treatment for the Therapy of Premalignant Mucosal Oral Lesions.

Resource links provided by NLM:


Further study details as provided by Dvorak Gabriella, Medical University of Vienna:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • pain due to treatment, assessed by visual analogue scale (VAS) [ Time Frame: each treatment, average once a week ]

Enrollment: 28
Study Start Date: May 2011
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aminolaevulinic acid Other: Aminolaevulinic acid
Photodynamic therapy
Placebo Comparator: Placebo Other: Methylcellulose Placebo
Methylcellulose

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497951

Locations
Austria
Bernhard Gottlieb University Clinic of Dentistry
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Study Director: Gabriella Dvorak, PD, DMD, MD Medical University Vienna
  More Information

Responsible Party: Dvorak Gabriella, Univ.Ass.DDr., senior staff at department of oral surgery, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01497951     History of Changes
Other Study ID Numbers: 2010_MuSH
Study First Received: December 9, 2011
Last Updated: May 16, 2017

Additional relevant MeSH terms:
Leukoplakia
Precancerous Conditions
Neoplasms
Pathological Conditions, Anatomical
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on July 21, 2017