Photodynamic Therapy for Oral Precursor Lesions

A Randomized Controlled Trial: Photodynamic Treatment for the Therapy of Premalignant Mucosal Oral Lesions.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01497951

Acronym

PDT

Enrollment

Registered

2011-12-23

Start date

2011-05-31

Completion date

2017-01-31

Last updated

2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukoplakia, Lichen

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.

Interventions

OTHERAminolaevulinic acid

Photodynamic therapy

OTHERMethylcellulose Placebo

Methylcellulose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
pain due to treatment, assessed by visual analogue scale (VAS)	each treatment, average once a week

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026