Oral Lichen Planus Treatment

Oral Lichen Planus Clinical Trial

Official title:

Oral Lichen Planus Photodynamic Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05127083
• Other study ID #: 2227/2018
• Status: Completed
• Phase: N/A
• Start date: June 4, 2018
• Est. completion date: October 18, 2021

Study information

• Verified date: November 2021
• Source: Universidad de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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%

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 18, 2021
• Est. primary completion date: October 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

Radiation:
• Patients will be treated with localized PBM with a diode laser
Toluidine blue was applied on the lesions.The tissue were irradiated with a 660-nm diode laser InGaAlP

Locations

Country	Name	City	State
Spain	Lopez-Jornet Pia	Murcia	N/A = Not Applicable

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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