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Long-Term Efficacy of 5-Aminolevulinic Acid Photodynamic Therapy in Oral Lichen Planus

Long-Term Efficacy of 5-Aminolevulinic Acid Photodynamic Therapy in Oral Lichen Planus - APOLLO

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00038334
Enrollment
28
Registered
2025-11-03
Start date
2017-05-01
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

K13

Interventions

Group 1: Participants received ten consecutive weekly sessions of photodynamic therapy using 5% 5-aminolevulinic acid (ALA) gel applied topically to oral lesions. The gel was protected with an occlusi

Sponsors

Medical University of Bialystok
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: histopathologically confirmed oral lichen planus

Exclusion criteria

Exclusion criteria: systemic diseases that may present with oral lesions, smoking, pregnancy or lactation, and treatment of oral lesions within the previous six months.

Design outcomes

Primary

MeasureTime frame
Change in Lesion Surface Area Measurement of oral lichen planus lesion size using a PCPUNC15 periodontal probe. Lesions categorized as no lesion, =1 cm2, >1 cm2 and =3 cm2, or >3 cm2. [Time Frame: Baseline (T0), immediately after treatment (T1), 12 months (T2), and 48 months (T3) after therapy.]

Secondary

MeasureTime frame
Change in REU Index (Reticulation-Erythema-Ulceration Score) Clinical severity of lesions assessed with the REU scoring system, which quantifies reticular, erythematous, and ulcerative components of oral lichen planus lesions. [Time Frame: Baseline (T0), immediately after treatment (T1), 12 months (T2), and 48 months (T3).] Change in Symptom Intensity (VAS Score) Patient-reported symptom severity, including pain and burning sensation, assessed with the Visual Analogue Scale (VAS; 0 = no symptoms, 10 = worst imaginable pain). [Time Frame: Baseline (T0), immediately after treatment (T1), 12 months (T2), and 48 months (T3).]

Countries

Poland

Contacts

Public ContactMagdalena Sulewska

Medical University of Bialystok

magdalena.sulewska@umb.edu.pl+48 7485905

Outcome results

None listed

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