Clinical trial NCT05127083: Oral Lichen Planus Treatment
Official title: Oral Lichen Planus Photodynamic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Lichen Planus
Keywords: pain, oral lichen planus ; photodynamic therapy
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: In this study, the efficacy of toluidine blue-mediated photodynamic therapy and topical triamcinolone acetonide 0.2% on decreasing pain and size of OLP lesions was compared.

This randomized, clinical trial compared the therapeutic effect of photodynamic therapy on symptomatic OLP (atrophic/ erosive/ulcerative forms) with triamcinolone acetonide 0.2%. The protocol of the clinical trial, which was conducted according to the ethical principles of Helsinki Group I toluidine blue-mediated photodynamic therapy Group II photodynamic therapy GroupIII laser sham + triamcinolone acetonide 0.2%

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change Assessment of Pain of OLP
timeFrame: Participants will be evaluated at baseline (Day 0) ; day 7: day 14 day and 28 day
measure: Change Thongprasom sign scoring
timeFrame: Participants will be evaluated at baseline (Day 0) ; day 7: day 14 day and 28 day
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Lopez-Jornet Pia
state: N/A = Not Applicable
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.