Oral Lichen Planus Treatment

NCT05127083 | Completed DMC

• 1 other identifier: 2227/2018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Oral lichen planus (OLP) is a chronic inflammatory and immune-mediated disease affecting the oral mucosa. OLP presents with asymptomatic, lacelike white stripes and/or symptomatic red, ulcerated mucous membranes. Eating, drinking and oral hygiene procedures may be painful resulting in reduced quality of life (QOL). Photodynamic therapy (PDT) is a new suggestion for OLP treatment PDT is a successful treatment mo- dality for premalignant and malignant diseases of head and neck,gastrointestinal tract, lung, and skin In this study, the effect of photodynamic therapy with topical corticosteroid in oral lichen planus patients was compared

Conditions

Oral Lichen Planus

Keywords

pain, oral lichen planus ; photodynamic therapy

Outcome Measures

Primary Outcomes (2)

• Change Assessment of Pain of OLP

  The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.

  Participants will be evaluated at baseline (Day 0) ; day 7: day 14 day and 28 day

• Change Thongprasom sign scoring

  a score of 0 for normal healthy mucosa, 1 for lesions with only white striae, 2 for mixed keratotic and atrophic or erythematous lesions \< 1 cm2 in size, 3 for keratotic and atrophic or erythematous lesions more than 1 cm2 in size, 4 for erosive/ulcerative lesions smaller than 1 cm2 , and 5 for erosive/ulcerative lesions larger than 1 cm2

  Participants will be evaluated at baseline (Day 0) ; day 7: day 14 day and 28 day

Study Arms (3)

toluidine blue-mediated photodynamic therapy

EXPERIMENTAL

The number of points will be variable according to the lesion size. Patients will be treated with localized PBM with a diode laser with continuous wave +toluidine blue

Radiation: Patients will be treated with localized PBM with a diode laser

photodynamic therapy + gel

ACTIVE COMPARATOR

The number of points will be variable according to the lesion size.atients will be treated with localized PBM with a diode laser with continuous wave

Radiation: Patients will be treated with localized PBM with a diode laser

acetonide triamcinolone 0.2%+sham

SHAM COMPARATOR

Patients will be treated with acetonide triamcinolone 0.2% for 30 consecutive days. Laser device will be positioned over the lesion but will be switched off to mask the treatment. Patients will be instructed to apply the gel in the entire lesion three times/days.The number of points will be variable according to the lesion size.

Radiation: Patients will be treated with localized PBM with a diode laser

Interventions

Patients will be treated with localized PBM with a diode laser RADIATION

Toluidine blue was applied on the lesions.The tissue were irradiated with a 660-nm diode laser InGaAlP

acetonide triamcinolone 0.2%+sham; photodynamic therapy + gel; toluidine blue-mediated photodynamic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients with clinical or histopathological diagnosis of bilateral atrophic or erosive OLP (symptomatic OLP) who signed the written consent form were recruited.

You may not qualify if:

• Patients with drug-induced or contact lichenoid reactions, patients receiving any treatment for OLP in 2 months prior to the study, pregnant or lactating women, patients with uncontrolled systemic disease, and patients with photosensitivity

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

Lopez-Jornet Pia

Murcia, N/A = Not Applicable, 30008, Spain

Location

Related Publications (5)

• Lavaee F, Shadmanpour M. Comparison of the effect of photodynamic therapy and topical corticosteroid on oral lichen planus lesions. Oral Dis. 2019 Nov;25(8):1954-1963. doi: 10.1111/odi.13188. Epub 2019 Oct 2.

  PMID: 31478283 BACKGROUND

• Hoseinpour Jajarm H, Asadi R, Bardideh E, Shafaee H, Khazaei Y, Emadzadeh M. The effects of photodynamic and low-level laser therapy for treatment of oral lichen planus-A systematic review and meta-analysis. Photodiagnosis Photodyn Ther. 2018 Sep;23:254-260. doi: 10.1016/j.pdpdt.2018.07.001. Epub 2018 Jul 10.

  PMID: 30006319 BACKGROUND

• Mostafa D, Moussa E, Alnouaem M. Evaluation of photodynamic therapy in treatment of oral erosive lichen planus in comparison with topically applied corticosteroids. Photodiagnosis Photodyn Ther. 2017 Sep;19:56-66. doi: 10.1016/j.pdpdt.2017.04.014. Epub 2017 Apr 25.

  PMID: 28450262 BACKGROUND

• Rakesh N, Clint JB, Reddy SS, Nagi R, Chauhan P, Sharma S, Sharma P, Kaur A, Shetty B, Ashwini S, Pavan Kumar T, Vidya GS. Clinical evaluation of photodynamic therapy for the treatment of refractory oral Lichen planus - A case series. Photodiagnosis Photodyn Ther. 2018 Dec;24:280-285. doi: 10.1016/j.pdpdt.2018.09.011. Epub 2018 Sep 24.

  PMID: 30261326 BACKGROUND

• Salinas-Gilabert C, Gomez Garcia F, Galera Molero F, Pons-Fuster E, Vander Beken S, Lopez Jornet P. Photodynamic Therapy, Photobiomodulation and Acetonide Triamcinolone 0.1% in the Treatment of Oral Lichen Planus: A Randomized Clinical Trial. Pharmaceutics. 2022 Dec 22;15(1):30. doi: 10.3390/pharmaceutics15010030.

  PMID: 36678659 DERIVED

MeSH Terms

Conditions

Lichen Planus, Oral; Pain

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigador principal Head Oral Medicine

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 19, 2021
• Study Start: June 4, 2018
• Primary Completion: October 3, 2020
• Study Completion: October 18, 2021
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)