Role and efficacy of topical 5-Aminolevulinic Acid (5-ALA) in Photodynamic detection (PDD) in determining malignant potential of oral lichen planus - PDD for Oral Lichen Planus

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004760-31-GB

Enrollment

Registered

2009-03-26

Start date

2007-04-17

Completion date

Unknown

Last updated

2017-04-03

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

Conditions

Oral Lichen Planus MedDRA version: 8.1 Level: LLT Classification code 10030983 Term: Oral lichen planus

Interventions

Trade Name: 5- amino-4-oxopentanoic acid sterile Product Name: 5-Aminolevulinate Product Code: 5-Aminolevulinate MC 506/1 Pharmaceutical Form: Powder and solvent for oral solution CAS Number: 5451-09-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Willingness to participate Oral Lesions including oral malignant disease affecting the mouth lining Able to use mouthwash for 15 minutes Able to comply with instructions Woman of child bearing age who are not pregnant Age 18-75 years Signed and dated consent form prior to application 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: Patients with obvious non-oral malignant disease Those unable to give informed consent Pregnant woman Patients with porphyria

Design outcomes

Primary

Measure	Time frame
Main Objective: To assist diagnosis of Oral Lichen planus non invasively so that surgical biopsy is not required by studying the characteristics of 5 aminolevulinic acid (ALA) induced protoporphyrin IX (PpIX) fluorescence in oral lesions.;Secondary Objective: To illuminate the borders of the lesion and establish if non malignant lesions give different readings of PpIX;Primary end point(s): Distinguish between Oral Lichen Planus and early stage cancer by detecting peaks in PpIX fluorescence	—

Measure

Time frame

Main Objective: To assist diagnosis of Oral Lichen planus non invasively so that surgical biopsy is not required by studying the characteristics of 5 aminolevulinic acid (ALA) induced protoporphyrin IX (PpIX) fluorescence in oral lesions.;Secondary Objective: To illuminate the borders of the lesion and establish if non malignant lesions give different readings of PpIX;Primary end point(s): Distinguish between Oral Lichen Planus and early stage cancer by detecting peaks in PpIX fluorescence

—

Countries

United Kingdom

Outcome results

None listed

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