A randomized controlled trial: Photodynamic Treatment for the therapy of premalignant mucosal oral lesions. - PDT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018399-25-AT

Enrollment

132

Registered

2011-02-22

Start date

2011-03-17

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Leukoplakia and oral lichen ruber. MedDRA version: 12.1 Level: LLT Classification code 10062037 Term: Leukoplakia MedDRA version: 12.1 Level: PT Classification code 10062037 Term: Leukoplakia MedDRA version: 12.1 Level: LLT Classification code 10030983 Term: Oral lichen planus

Interventions

Product Name: 5-Aminolevulinic acid hydrochloride Product Code: 5-ALA Pharmaceutical Form: Oromucosal gel INN or Proposed INN: 5-ALA CAS Number: 02/09/5451 Other descriptive name: AMINOLEVULINIC ACID

Eligibility

Sex/Gender

All

Inclusion 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 (at least 4 weeks before beginning of the study). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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
Main Objective: Establishment of standard minutes for the treatment of precancer-lesionen, therapy alternatives to the surgical Excision of mouth mucous membrane changes and secondary prevention of an oral disk epithelium carcinoma.;Secondary Objective: Mucosal changes over time;Primary end point(s): Size (in %) of the mouth mucous membrane change	—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026