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Photodynamic Therapy for Oral Precursor Lesions (PDT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Medical University of Vienna.
Recruitment status was  Recruiting
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
  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:


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
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 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
Neoplasms
Pathological Conditions, Anatomical
Precancerous Conditions
Aminolevulinic Acid
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014