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Photodynamic Therapy for Oral Precursor Lesions (PDT)

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ClinicalTrials.gov Identifier: NCT01497951
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Dvorak Gabriella, Medical University of Vienna

Brief Summary:
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 or disease Intervention/treatment Phase
Leukoplakia Lichen Other: Aminolaevulinic acid Other: Methylcellulose Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial: Photodynamic Treatment for the Therapy of Premalignant Mucosal Oral Lesions.
Study Start Date : May 2011
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017


Arm Intervention/treatment
Experimental: Aminolaevulinic acid Other: Aminolaevulinic acid
Photodynamic therapy

Placebo Comparator: Placebo Other: Methylcellulose Placebo
Methylcellulose




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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 23, 2011    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017

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