Photobiomodulation in Oral Lichen Planus

NCT03320460 | Unknown DMC

• 1 other identifier: 2.375.410
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to compare the efficacy of PBM (660nm) and corticosteroid therapy with clobetasol propionate 0.05% in the treatment of OLP. This is a protocol for a randomized, controlled, double blind clinical trial. Fourty-four patients will be randomized in two experimental groups. Control group will be treated with clobetasol propionate 0.05% for 30 consecutive days and with placebo PBM twice a week. The experimental group will be treated with placebo gel for 30 consecutive days to mask the treatment and patients will receive PBM twice a week during 1 month (laser λ = 660±10 nm; power 100mW; radiant energy 177J/cm2; 5-s exposure time per point and 0.5J of energy per point. The primary variable (pain) and the secondary variables including clinical scores and functional scores as well as patient anxiety and depression (The Hospital Anxiety and Depression Scale-HADS), will be evaluated at the baseline, once a week during treatment and after 30 and 60 days of follow up. Evaluation of clinical resolution will be performed at the end of the treatment (30 days). Evaluation of recurrence will be performed after 30 and 60 days of follow up. Serum and salivary levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated at baseline and at the end of treatment (30 days). Quality of life will be evaluated by OHIP-14 questionnaire at baseline, at the end of treatment and after 30 and 60 days of follow up. The chi-square test, Student's t-test and ANOVA will be used and the level of significance of 5% will be considered (p \< 0.05).

Conditions

Lichen Planus, Oral; Low-Level Light Therapy

Keywords

oral lichen planus; photobiomodulation; inflammation

Outcome Measures

Primary Outcomes (7)

• 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)

• 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 after 1 week of treatment (Day 7)

• 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 after 2 weeks of treatment (Day 14)

• 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 after 3 weeks of treatment (Day 21)

• 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 after 4 weeks of treatment (Day 30)

• 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.

  30 days after the discontinuation of treatment (follow-up period)

• 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.

  60 days after the discontinuation of treatment (follow-up period)

Secondary Outcomes (32)

• Assessment of clinical presentation of OLP

  Participants will be evaluated at baseline (Day 0)

• Assessment of clinical presentation of OLP

  Participants will be evaluated after 1 week of treatment (Day 7)

• Assessment of clinical presentation of OLP

  Participants will be evaluated after 2 weeks of treatment (Day 14)

• Assessment of clinical presentation of OLP

  Participants will be evaluated after 3 weeks of treatment (Day 21)

• Assessment of clinical presentation of OLP

  Participants will be evaluated after 4 weeks of treatment (Day 30)

Study Arms (2)

Photobiomodulation

EXPERIMENTAL

Patients will be treated with localized PBM with a diode laser with continuous wave (laser λ =660 nm; power 100mW;radiant energy: 177J/cm2; 5-s exposure time per point and 0.5J of energy per point) applied directly to the surrounding oral mucosa and to the center of OLP, always by the same operator, twice a week for 4 weeks, totaling 8 session. The number of points will be variable according to the lesion size. The output power of the laser equipment will be evaluated using a power meter (Laser Check; MMOptics LTDA, São Paulo, Brazil) before treatment to confirm the effective mean power as well as the doses applied during the procedure.

Device: Photobiomodulation; Other: Placebo gel

Propionate clobetasol gel 0.05%

ACTIVE COMPARATOR

Patients will be treated with Propionate clobetasol gel 0.05% 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 propionate clobetasol gel 0.05% in the entire lesion three times/days. To prevent oral candidiasis, patients will use micostatin solution (Nystatin oral suspension 100,000 USP/ml) once a day during 4 weeks.

Drug: Propionate clobetasol gel 0.05%; Other: Placebo Photobiomodulation

Interventions

Propionate clobetasol gel 0.05% DRUG

Patients will be treated with Propionate clobetasol gel 0.05% for 30 consecutive days and with placebo laser twice a week. Patients will be instructed to apply the propionate clobetasol gel 0.05% in the entire lesion three times/days. To prevent oral candidiasis, patients will use micostatin solution (Nystatin oral suspension 100,000 USP/ml) once a day during 4 weeks.

Also known as: Clobetasol

Propionate clobetasol gel 0.05%

Photobiomodulation DEVICE

Patients will be treated with localized PBM with a diode laser with continuous wave (laser λ = 660 nm; power 100mW;radiant energy: 177J/cm2; 5-s exposure time per point and 0.5J of energy per point) applied directly to the surrounding oral mucosa and to the center of OLP, always by the same operator, twice a week for 4 weeks, totaling 8 session. The number of points will be variable according to the lesion size. The output power of the laser equipment will be evaluated using a power meter (Laser Check; MMOptics LTDA, São Paulo, Brazil) before treatment to confirm the effective mean power as well as the doses applied during the procedure.

Also known as: Low level laser therapy

Photobiomodulation

Placebo gel OTHER

Placebo gel for 30 consecutive days to mask the treatment

Also known as: inative gel

Photobiomodulation

Placebo Photobiomodulation OTHER

Laser device will be positioned over the lesion but will be switched off to mask the treatment.

Also known as: Laser off

Propionate clobetasol gel 0.05%

Eligibility Criteria

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

You may qualify if:

• The participants in this study will be male and female (aged over 18 years) diagnosed with symptomatic oral lichen planus, based on the clinical and histopathological criteria of the World Health Organization (WHO).

You may not qualify if:

• Patients with ongoing cancer; pregnant or breastfeeding women; patients with history of corticosteroids and nonsteroidal anti-inflammatory treatment in the last one months, patients with uncontrolled systemic disease; consumption of illicit drugs; use of medication associated with oral lichenoid reactions; amalgam restoration near to OLP lesions; epithelial dysplasia in the histopathological examination.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Scholl of Dentistry, University of São Paulo

São Paulo, São Paulo, 05508000, Brazil

RECRUITING

Related Publications (12)

• Akram Z, Abduljabbar T, Vohra F, Javed F. Efficacy of low-level laser therapy compared to steroid therapy in the treatment of oral lichen planus: A systematic review. J Oral Pathol Med. 2018 Jan;47(1):11-17. doi: 10.1111/jop.12619. Epub 2017 Aug 21.

  PMID: 28766756 BACKGROUND

• Dillenburg CS, Martins MA, Munerato MC, Marques MM, Carrard VC, Sant'Ana Filho M, Castilho RM, Martins MD. Efficacy of laser phototherapy in comparison to topical clobetasol for the treatment of oral lichen planus: a randomized controlled trial. J Biomed Opt. 2014 Jun;19(6):068002. doi: 10.1117/1.JBO.19.6.068002.

  PMID: 24887747 BACKGROUND

• Sulewska M, Duraj E, Sobaniec S, Graczyk A, Milewski R, Wroblewska M, Pietruski J, Pietruska M. A clinical evaluation of the efficacy of photodynamic therapy in the treatment of erosive oral lichen planus: A case series. Photodiagnosis Photodyn Ther. 2017 Jun;18:12-19. doi: 10.1016/j.pdpdt.2017.01.178. Epub 2017 Jan 22.

  PMID: 28119140 BACKGROUND

• DeLand MM, Weiss RA, McDaniel DH, Geronemus RG. Treatment of radiation-induced dermatitis with light-emitting diode (LED) photomodulation. Lasers Surg Med. 2007 Feb;39(2):164-8. doi: 10.1002/lsm.20455.

  PMID: 17311276 BACKGROUND

• Nogueira PA, Carneiro S, Ramos-e-Silva M. Oral lichen planus: an update on its pathogenesis. Int J Dermatol. 2015 Sep;54(9):1005-10. doi: 10.1111/ijd.12918. Epub 2015 Jul 3.

  PMID: 26147778 BACKGROUND

• Alrashdan MS, Cirillo N, McCullough M. Oral lichen planus: a literature review and update. Arch Dermatol Res. 2016 Oct;308(8):539-51. doi: 10.1007/s00403-016-1667-2. Epub 2016 Jun 27.

  PMID: 27349424 BACKGROUND

• Thongprasom K, Luangjarmekorn L, Sererat T, Taweesap W. Relative efficacy of fluocinolone acetonide compared with triamcinolone acetonide in treatment of oral lichen planus. J Oral Pathol Med. 1992 Nov;21(10):456-8. doi: 10.1111/j.1600-0714.1992.tb00974.x.

  PMID: 1460584 BACKGROUND

• Lilleby K, Garcia P, Gooley T, McDonnnell P, Taber R, Holmberg L, Maloney DG, Press OW, Bensinger W. A prospective, randomized study of cryotherapy during administration of high-dose melphalan to decrease the severity and duration of oral mucositis in patients with multiple myeloma undergoing autologous peripheral blood stem cell transplantation. Bone Marrow Transplant. 2006 Jun;37(11):1031-5. doi: 10.1038/sj.bmt.1705384.

  PMID: 16633359 BACKGROUND

• Carrozzo M, Gandolfo S, Lodi G, Carbone M, Garzino-Demo P, Carbonero C, Porter SR, Scully C. Oral lichen planus in patients infected or noninfected with hepatitis C virus: the role of autoimmunity. J Oral Pathol Med. 1999 Jan;28(1):16-9. doi: 10.1111/j.1600-0714.1999.tb01988.x.

  PMID: 9890452 BACKGROUND

• Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.

  PMID: 9332805 BACKGROUND

• Sobral SS, da Silva Brandao EH, de Barros Gallo C, Molon A, Sobral APT, de Fatima Teixeira da Silva D, Motta LJ, Dos Santos Franco AL, Rodrigues MFSD. Analysis of the psychopathological profile, quality of life, and cost-effectiveness of oral lichen planus patients treated with photobiomodulation. Clin Oral Investig. 2022 Jan;26(1):719-728. doi: 10.1007/s00784-021-04050-z. Epub 2021 Jul 12.

  PMID: 34251533 DERIVED

• Ferri EP, Gallo CB, Abboud CS, Yanaguizawa WH, Horliana ACRT, Silva DFTD, Pavani C, Bussadori SK, Nunes FD, Mesquita-Ferrari RA, Fernandes KPS, Rodrigues MFSD. Efficacy of photobiomodulation on oral lichen planus: a protocol study for a double-blind, randomised controlled clinical trial. BMJ Open. 2018 Oct 8;8(10):e024083. doi: 10.1136/bmjopen-2018-024083.

  PMID: 30297352 DERIVED

MeSH Terms

Conditions

Lichen Planus, Oral; Inflammation

Interventions

Clobetasol; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Maria Fernanda SD Rodrigues, PhD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Paula C Silva, Bachelor

CONTACT

+ 55 11 3385-9197; aninha@uninove.br

Anna Carolina RT Horliana, PhD

CONTACT

+55 13 981999848; annacrth@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Control group will be treated with clobetasol propionate 0.05% gel for 30 consecutive days and the laser device will be positioned over the lesion but will be switched off to mask the treatment. The experimental group will be treated with placebo gel for 30 consecutive days to mask the treatment and patients will receive laser treatment twice a week during 1 month for PBM
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Control group Experimental Group

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: October 25, 2017
• Study Start: November 1, 2018
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 26, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)