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Search / Trial NCT05401201

Dual-light Antibacterial Photodynamic Therapy as an Adjunctive Treatment to Corticosteroid Treatment in OLP

Launched by KOITE HEALTH OY · Jun 1, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Lumoral Lumorinse Plaque Oral Lichen Planus A Mmp 8 A Pdt Pain Score (Vas)

ClinConnect Summary

This clinical trial is studying a new treatment approach for Oral Lichen Planus (OLP), a condition that can cause painful sores in the mouth. Researchers are looking at a device called Lumoral, which uses light to help control dental plaque and reduce oral bacterial infections. The trial will compare the effectiveness of this device to a standard mouth rinse containing a corticosteroid called triamcinolone acetonide (TCA). Participants will use the Lumoral device at home while following specific treatment guidelines, and their symptoms will be monitored.

To be eligible for this study, participants should be aged between 65 and 74 years, have a confirmed diagnosis of OLP with specific symptoms, and be able to give written consent. They should also be willing to follow the study's treatment plan without using other oral hygiene products. However, individuals who have had recent treatments for OLP, are pregnant or breastfeeding, have certain allergies, or have taken antibiotics recently won't be able to participate. Those who join the study can expect regular check-ins and will need to fill out questionnaires about their experience. This trial offers a chance to explore a potentially new and effective treatment for OLP.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Histologically confirmed diagnosis of OLP with bilateral symmetrical lesions and gingival involvement
  • Able to provide a written consent
  • Willing and able to complete questionnaires
  • Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol
  • Exclusion Criteria:
  • Lichenoid lesions suspected to be induced by contact allergy or drugs
  • Any treatment for OLP in two weeks prior to the study/ a history of topical therapy for OLP in the past 2 weeks or systemic therapy in the past 4 weeks;
  • Pregnant or lactating
  • Photosensitivity
  • Use of antibiotics within 2 weeks prior the study

About Koite Health Oy

Koite Health Oy is a pioneering clinical trial sponsor dedicated to advancing healthcare through innovative research and development. Based in Finland, the company specializes in designing and managing clinical trials that focus on cutting-edge therapies and medical technologies. With a commitment to improving patient outcomes, Koite Health Oy leverages a team of experienced professionals and robust methodologies to ensure the highest standards of quality and compliance throughout the research process. By fostering collaborations with healthcare providers and stakeholders, Koite Health Oy aims to bring transformative solutions to the market, enhancing the efficacy and accessibility of treatments for various medical conditions.

Locations

Tampere, Pirkanmaa, Finland

Tampere, Pirkanmaa, Finland

Tampere, Pirkanmaa, Finland

Patients applied

0 patients applied

Trial Officials

Tommi Pätilä, Docent

Study Director

Chief Medical Officer

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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