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

December 9, 2011
December 22, 2011
May 2011
May 2012   (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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01497951 on ClinicalTrials.gov Archive Site
pain due to treatment, assessed by visual analogue scale (VAS) [ Time Frame: each treatment, average once a week ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Leukoplakia
  • Lichen
  • Other: Aminolaevulinic acid
    Photodynamic therapy
  • Other: Methylcellulose Placebo
    Methylcellulose
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
132
May 2012
May 2012   (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
Both
18 Years and older
No
Not Provided
Austria
 
NCT01497951
2010_MuSH
No
Dvorak Gabriella, Medical University of Vienna
Medical University of Vienna
Not Provided
Study Chair: Georg Watzek, Prof. Medical University Vienna
Medical University of Vienna
December 2011

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