Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Photobiomodulation in Oral Lichen Planus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03320460
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Maria Fernanda Setúbal Destro Rodrigues, University of Nove de Julho

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).

Condition or disease Intervention/treatment Phase
Lichen Planus, Oral Low-Level Light Therapy Drug: Propionate clobetasol gel 0.05% Device: Photobiomodulation Other: Placebo gel Other: Placebo Photobiomodulation Not Applicable

Detailed Description:

Oral lichen planus is an idiopathic chronic mucocutaneous disease with a ride range of clinical manifestations, including white reticular patches, erosive/ulcerative and atrophic lesions, both associated with intense symptomatology. CD4+ and CD8+ T lymphocytes cells play an important role in the pathogenesis of OLP and are responsible for the production of different cytokines, including IL-6, IL-10, IL-1β, INF-γ and TNF-α. Treatment is symptomatic and topical corticosteroids are commonly used as standard therapy. However, patients frequently present relapses after treatment's discontinuation, develop resistance to corticosteroids therapy as well as secondary candidiasis. Photobiomodulation (PBM) has shown to be a potential therapeutic tool to treat inflammatory disorders, including OLP. Some studies have demonstrated that PBM improves the clinical presentation of OLP (erosive/ulcerative or atrophic lesions to reticular lesions), reduces pain and recurrence. However, it remains controversy if PBM is more effective than corticosteroid in the treatment of OLP. The aim of this study is to evaluate the efficacy of PBM in the treatment of OLP in relation to the standard therapy with corticosteroids. This is a protocol for a randomized, controlled, doubled blind clinical trial, with two months of follow up.

Patients with symptomatic OLP and with histopathological diagnosis of OLP based on WHO criteria will be included in this study. Fourty-four patients will be randomized in two experimental groups. 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 (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 by VAS scale) and the secondary variables (clinical scores, functional scores and Patient anxiety and depression) 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 findings will be computed and submitted to statistical analysis. Interval estimates will be used for the variables of interest to determine the prevision of the estimates and perform comparisons. If necessary, transformation methods or non-parametric tests will be applied. 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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Control group Experimental Group
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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
Primary Purpose: Treatment
Official Title: Efficacy of Photobiomodulation for Oral Lichen Planus Treatment
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Photobiomodulation
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
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.
Other Name: Low level laser therapy

Other: Placebo gel
Placebo gel for 30 consecutive days to mask the treatment
Other Name: inative gel

Active Comparator: Propionate clobetasol gel 0.05%
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%
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.
Other Name: Clobetasol

Other: Placebo Photobiomodulation
Laser device will be positioned over the lesion but will be switched off to mask the treatment.
Other Name: Laser off




Primary Outcome Measures :
  1. Assessment of Pain of OLP [ Time Frame: Participants will be evaluated at baseline (Day 0) ]
    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.

  2. Assessment of Pain of OLP [ Time Frame: Participants will be evaluated after 1 week of treatment (Day 7) ]
    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.

  3. Assessment of Pain of OLP [ Time Frame: Participants will be evaluated after 2 weeks of treatment (Day 14) ]
    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.

  4. Assessment of Pain of OLP [ Time Frame: Participants will be evaluated after 3 weeks of treatment (Day 21) ]
    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.

  5. Assessment of Pain of OLP [ Time Frame: Participants will be evaluated after 4 weeks of treatment (Day 30) ]
    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.

  6. Assessment of Pain of OLP [ Time Frame: 30 days after the discontinuation of treatment (follow-up period) ]
    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.

  7. Assessment of Pain of OLP [ Time Frame: 60 days after the discontinuation of treatment (follow-up period) ]
    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.


Secondary Outcome Measures :
  1. Assessment of clinical presentation of OLP [ Time Frame: Participants will be evaluated at baseline (Day 0) ]
    Clinical data will be evaluated by scores according to Thongprasom et al

  2. Assessment of clinical presentation of OLP [ Time Frame: Participants will be evaluated after 1 week of treatment (Day 7) ]
    Clinical data will be evaluated by scores according to Thongprasom et al

  3. Assessment of clinical presentation of OLP [ Time Frame: Participants will be evaluated after 2 weeks of treatment (Day 14) ]
    Clinical data will be evaluated by scores according to Thongprasom et al

  4. Assessment of clinical presentation of OLP [ Time Frame: Participants will be evaluated after 3 weeks of treatment (Day 21) ]
    Clinical data will be evaluated scores according to Thongprasom et al

  5. Assessment of clinical presentation of OLP [ Time Frame: Participants will be evaluated after 4 weeks of treatment (Day 30) ]
    Clinical data will be evaluated by scores according to Thongprasom et al

  6. Assessment of clinical presentation of OLP [ Time Frame: 30 days after the discontinuation of treatment (follow-up period) ]
    Clinical data will be evaluated by scores according to Thongprasom et al

  7. Assessment of clinical presentation of OLP [ Time Frame: 60 days after the discontinuation of treatment (follow-up period) ]
    Clinical data will be evaluated by scores according to Thongprasom et al

  8. Function [ Time Frame: Participants will be evaluated at baseline (Day 0) ]
    The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).

  9. Function [ Time Frame: Participants will be evaluated after 1 week of treatment (Day 7) ]
    The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).

  10. Function [ Time Frame: Participants will be evaluated after 2 weeks of treatment (Day 14) ]
    The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).

  11. Function [ Time Frame: Participants will be evaluated after 3 weeks of treatment (Day 21) ]
    The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).

  12. Function [ Time Frame: Participants will be evaluated after 4 weeks of treatment (Day 30) ]
    The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).

  13. Function [ Time Frame: 30 days after the discontinuation of treatment (follow-up period) ]
    The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).

  14. Function [ Time Frame: 60 days after the discontinuation of treatment (follow-up period) ]
    The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).

  15. Clinical Resolution [ Time Frame: Participants will be evaluated after 4 weeks of treatment (Day 30) ]
    The clinical resolution will be evaluated at the end of treatment (day 30) according to Corozzo et al. (1999). Complete resolution will be considered when patients present absence of symptoms and remission of atrophic/erosive lesions regardless the presence of any persisting hyperkeratotic lesions. Partial resolution will be considered when a decrease but not the complete remission of atrophic/erosive areas and symptoms were observed. No response to treatment will be considered when OLP lesions present the same clinical or worse presentation in relation to the baseline condition.

  16. Recurrence rate [ Time Frame: The recurrence rate will be evaluated 30 days after the discontinuation of treatment (follow-up period) ]
    No recurrence will be considered when the patient presents the same clinical aspect of lesion at the end of treatment and recurrence, when the patient present new atrophic/erosive lesion at the same site during the follow-up period.

  17. Recurrence rate [ Time Frame: The recurrence rate will be evaluated 60 days after the discontinuation of treatment (follow-up period) ]
    No recurrence will be considered when the patient presents the same clinical aspect of lesion at the end of treatment and recurrence, when the patient present new atrophic/erosive lesion at the same site during the follow-up period.

  18. Salivary levels of IL-1β, IL-6, IL-8, IL-10 and TNFα [ Time Frame: Baseline (day 0) ]
    The samples will be centrifuged and stored at -80°C. Salivary levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated by Enzyme Linked Immune Sorbent Assay (ELISA), according to manufacturer's instructions.

  19. Salivary levels of IL-1β, IL-6, IL-8, IL-10 and TNFα [ Time Frame: After 4 weeks of treatment (Day 30) ]
    The samples will be centrifuged and stored at -80°C. Salivary levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated by Enzyme Linked Immune Sorbent Assay (ELISA), according to manufacturer's instructions.

  20. Serum levels of IL-1β, IL-6, IL-8, IL-10 and TNFα [ Time Frame: Baseline (Day 0) ]
    Peripheral blood will be centrifuged at 400xg for 10 min at 4°C. Serum will be collected and stored at -80°C. Serum levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated by Enzyme Linked Immune Sorbent Assay (ELISA), according to manufacturer's instructions.

  21. Serum levels of IL-1β, IL-6, IL-8, IL-10 and TNFα [ Time Frame: After 4 weeks of treatment (Day 30) ]
    Peripheral blood will be centrifuged at 400xg for 10 min at 4°C. Serum will be collected and stored at -80°C. Serum levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated by Enzyme Linked Immune Sorbent Assay (ELISA), according to manufacturer's instructions.

  22. Assessment of Quality of life in OLP patients [ Time Frame: Baseline (Day 0) ]
    Patient quality of life will be measured by means of the Oral Health Impact Profile (OHIP 14)

  23. Assessment of Quality of life in OLP patients [ Time Frame: After 4 weeks of treatment (Day 30) ]
    Patient quality of life will be measured by means of the Oral Health Impact Profile (OHIP 14)

  24. Assessment of Quality of life in OLP patients [ Time Frame: 30 days after the discontinuation of treatment (follow-up period) ]
    Patient quality of life will be measured by means of the Oral Health Impact Profile (OHIP 14)

  25. Assessment of Quality of lifein OLP patients [ Time Frame: 60 days after the discontinuation of treatment (follow-up period) ]
    Patient quality of life will be measured by means of the Oral Health Impact Profile (OHIP 14)

  26. Anxiety and Depression [ Time Frame: Baseline (Day 0) ]
    Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)

  27. Anxiety and Depression [ Time Frame: Participants will be evaluated after 1 week of treatment (Day 7) ]
    Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)

  28. Anxiety and Depression [ Time Frame: Participants will be evaluated after 2 weeks of treatment (Day 14) ]
    Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)

  29. Anxiety and Depression [ Time Frame: Participants will be evaluated after 3 weeks of treatment (Day 21) ]
    Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)

  30. Anxiety and Depression [ Time Frame: Participants will be evaluated after 4 weeks of treatment (Day 30) ]
    Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)

  31. Anxiety and Depression [ Time Frame: 30 days after the discontinuation of treatment (follow-up period) ]
    Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)

  32. Anxiety and Depression [ Time Frame: 60 days after the discontinuation of treatment (follow-up period) ]
    Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320460


Contacts
Layout table for location contacts
Contact: Ana Paula C Silva, Bachelor + 55 11 3385-9197 aninha@uninove.br
Contact: Anna Carolina RT Horliana, PhD +55 13 981999848 annacrth@gmail.com

Locations
Layout table for location information
Brazil
Scholl of Dentistry, University of São Paulo Recruiting
São Paulo, SP, Brazil, 05508000
Contact: Camilla Barros Gallo, PhD    1130917883    fernandarodrigues@uni9.pro.br   
Principal Investigator: Maria F Rodrigues, PhD         
Sub-Investigator: Camila B Gallo, PhD         
Sponsors and Collaborators
University of Nove de Julho
Investigators
Layout table for investigator information
Principal Investigator: Maria Fernanda SD Rodrigues, PhD University of Nove de Julho

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Maria Fernanda Setúbal Destro Rodrigues, Professor, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT03320460     History of Changes
Other Study ID Numbers: 2.375.410
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Fernanda Setúbal Destro Rodrigues, University of Nove de Julho:
oral lichen planus; photobiomodulation; inflammation
Additional relevant MeSH terms:
Layout table for MeSH terms
Lichen Planus, Oral
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Clobetasol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs