PDT: Photodynamic Therapy for Oral Precursor Lesions

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Completed
• CT.gov ID: NCT01497951
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 68.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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 1, 2011
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aminolaevulinic acid	Other: Aminolaevulinic acid; Photodynamic therapy
Placebo Comparator: Placebo	Other: Methylcellulose Placebo; Methylcellulose

Outcome Measures

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. [each treatment average once a week, recall after 4 weeks]

Secondary Outcome Measures

1. pain due to treatment, assessed by visual analogue scale (VAS) [each treatment, average once a week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dvorak Gabriella, Univ.Ass.DDr., senior staff at department of oral surgery, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT01497951
• Other Study ID Numbers: 2010_MuSH
• First Posted: Dec 23, 2011
• Last Update Posted: May 17, 2017
• Last Verified: May 1, 2017

• Additional relevant MeSH terms: Leukoplakia

Study Results

No Results Posted as of May 17, 2017