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Photodynamic Therapy for Oral Precursor Lesions (PDT)

This study is currently recruiting participants.
Verified December 2011 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Dvorak Gabriella, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01497951
First received: December 9, 2011
Last updated: December 22, 2011
Last verified: December 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial: Photodynamic Treatment for the Therapy of Premalignant Mucosal Oral Lesions.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain due to treatment, assessed by visual analogue scale (VAS) [ Time Frame: each treatment, average once a week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 132
Study Start Date: May 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497951

Locations
Austria
Bernhard Gottlieb University Clinic of Dentistry Recruiting
Vienna, Austria, 1090
Contact: Gabriella Dvorak     400704144     gabriella.dvorak@meduniwien.ac.at    
Sponsors and Collaborators
Medical University of Vienna
Investigators
Study Chair: Georg Watzek, Prof. Medical University Vienna
  More Information

No publications provided

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: December 22, 2011
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Leukoplakia
Precancerous Conditions
Neoplasms
Pathological Conditions, Anatomical
Aminolevulinic Acid
Photosensitizing Agents
 Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013