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Management of Pain in Oral Lichen Planus

Primary Purpose

Oral Lichen Planus

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
0.1 % topical triamcinolone acetonide
SIROIaser
Sponsored by
Sherine Adel Nasry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oral Lichen Planus

Eligibility Criteria

45 Years - 62 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • histological diagnosis of OLP on the basis of WHO criteria (Meji and van der Waal 2003).
  • presence of painful and atrophic-erosive oral lesions, unresponsive to topical corticosteroid therapy
  • ability to complete the present clinical trial.

Exclusion Criteria:

  • Presence of histological signs of dysplasia
  • use of lichenoid reaction inducing drugs
  • Therapy for OLP in the 2 months prior to the study;
  • Patients suffering from any disease that may present with features similar to OLP (graft versus host disease or lupus erythematosus)
  • Pregnant or lactating females
  • Patients with uncontrolled diabetes or hypertension, positive HCV Ab or HBs Ag.
  • Smokers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    comparison group (active control)

    experimental group

    Arm Description

    0.1 % topical triamcinolone acetonide preparation (Kenacourt-A Orabase Pomad, DEVA HOLDINGS A.S., Istanbul, Turkey) was used where the patients' were instructed to apply the gel 4 times daily, with no food or fluid taken one hour after application. Patients used the medication for 4 weeks , and if extension of treatment was required after that period , patients were instructed to apply miconazole oral gel (JANSSEN-CILAG Pty Ltd 1-5 Khartoum Road North Ryde NSW 2113 Australia) four times a day for one week to protect from superimposed fungal infections.15

    OLP lesions were irradiated with a 970-nm diode laser (SIRO Laser Advance class III b, SIRONA, Germany) with a 2 W irradiation power in a continuous non-contact mode. The laser beam was delivered using a fiber-optic tip with a 320 µm diameter with defocused mode directed at the lesions plus 0.5 cm peri- lesional tissues with a slight overlapping in order to evenly distribute energy covering all the lesional and peri-lesional tissues until blanching of the area was observed.14 Diode laser was calibrated to an output power of 3W, frequency of 30 Hz, energy of 180 joule and time interval of 8 minutes divided into 4 sessions , two min each with one minute rest in between to allow for tissue relaxation. Irradiation was done twice weekly for two months until the resolution of signs for a maximum of ten sessions.11 After each session, patients were advised to have a cold diet and use chlorhexidine oral gel postoperatively twice a day to the lesion for one week.

    Outcomes

    Primary Outcome Measures

    change in VAS
    Visual Analogue Scale (VAS) The pain VAS is a continuous single-item scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme Range: 0-10 (cm) no pain (0-0.4 cm), mild pain (0.55-4.4 cm), moderate pain (4.5-7.4)cm, and severe pain (7.5- 10) cm A higher score indicates greater pain intensity

    Secondary Outcome Measures

    change in RAE
    The Reticular, Atrohpic, Erosive ( RAE ) scale used by Thongprasom and co-workers records and measures the clinical appearance of the Oral Lichen Planus) OLP lesion Score range: 0-5 with o being the most favorable clinical appearance and 5 the most severe clinical appearance. score 0: no lesions; score 1: hyperkeratotic lesions score 2: atrophic area ≤1 cm2 score 3: atrophic area >1 cm2 score 4: erosive area ≤1 cm2 score 5: erosive area >1 cm2

    Full Information

    First Posted
    June 19, 2018
    Last Updated
    June 30, 2018
    Sponsor
    Sherine Adel Nasry
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03572959
    Brief Title
    Management of Pain in Oral Lichen Planus
    Official Title
    Management of Pain in Oral Lichen Planus Patients: A Comparative Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 27, 2016 (Actual)
    Primary Completion Date
    March 20, 2017 (Actual)
    Study Completion Date
    May 22, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Sherine Adel Nasry

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Treating Oral Lichen Planus (OLP) is a big challenge for clinicians. Despite numerous existing remedies, to date no effective cure has been found, which is mainly attributed to the lack of understanding of the pathogenesis of the disease. The investigator's aim was comparing the effectiveness of topical steroids and diode laser in treating OLP patients. Twenty-four patients with OLP were allocated into two groups of twelve patients each. One group was treated with 970 nm diode laser applied twice weekly and the other group was treated with topical steroids applied four times per day. Patients were followed up for two months. Pain was recorded using the visual analog score (VAS) and the clinical signs and symptoms were recorded using the reticular, atrophic, erosive (RAE) sores. Pain and RAE records were taken before treatment, after treatment and after 2 months.
    Detailed Description
    24 patients (16 females , 8 males ) were recruited in this study from the Dental Clinic of the National Research Centre, Egypt, and the Ethical Committee approved the study protocol. All patients were informed about the treatment plan and they all submitted a written informed consent before enrolment, which was carried out in accordance with the declaration of Helsinki. Inclusion criteria included oral lesions clinically and histopathologically consistent with the modifications for the WHO 2003 criteria suggested by van der Meij and van der Waal.13 Patients were excluded from the study in case of indefinite diagnosis (such as lichenoid inflammation); or those suffering from any disease that may present with features similar to OLP (graft versus host disease or lupus erythematosus),if they received any medication for OLP treatment in the two months prior enrolment in the study, if they were pregnant or lactating women, or if histological diagnosis revealed lichenoid changes or any signs of dysplasia. 4,14 Study design: Patients were randomly divided into two groups using a randomization software, where a blocked randomization was used to ascertain equal distribution of patients into each group (parallel-group study).15 One group (12 patients) was irradiated with diode laser and the other group was treated with topical steroids. In the laser group, normal protective measures were taken, where patients and personnel wore laser safety glasses . OLP lesions were irradiated with a 970-nm diode laser (SIRO Laser Advance class III b, SIRONA, Germany) with a 2 W irradiation power in a continuous non-contact mode. The laser beam was delivered using a fiber-optic tip with a 320 µm diameter with defocused mode directed at the lesions plus 0.5 cm peri- lesional tissues with a slight overlapping in order to evenly distribute energy covering all the lesional and peri-lesional tissues until blanching of the area was observed.14 Diode laser was calibrated to an output power of 3W, frequency of 30 Hz, energy of 180 joule and time interval of 8 minutes divided into 4 sessions , two min each with one minute rest in between to allow for tissue relaxation. Irradiation was done twice weekly (once every third day) for two months until the resolution of signs (meaning the resolution of all atrophic-erosive lesions, regardless of any persisting hyperkeratotic lesions) for a maximum of ten sessions.11 After each session, patients were advised to have a cold diet and use chlorhexidine oral gel postoperatively. The patients applied the gel twice a day to the lesion for one week.16 For the steroid group (12 patients), 0.1 % topical triamcinolone acetonide preparation (Kenacourt-A Orabase Pomad, DEVA HOLDINGS A.S., Istanbul, Turkey) was used where the patients' were instructed to apply the gel 4 times daily, with no food or fluid taken one hour after application. Patients used the medication for 4 weeks , and if extension of treatment was required after that period , patients were instructed to apply miconazole oral gel (JANSSEN-CILAG Pty Ltd 1-5 Khartoum Road North Ryde NSW 2113 Australia) four times a day for one week to protect from superimposed fungal infections.15 Scoring of the clinical signs was done according to the RAE (Reticular, Erosive, Atrophic ) scale of Thongprasom and co- workers.17 Total improvement of the clinical signs was given scores zero or one and was defined as the disappearance of all atrophic-erosive lesions, whether any hyperkeratotic lesions persisted or not. Partial improvement or persisting of the patient's condition meant a decrease (score 2, 3 or 4), or no improvement (no change in the patient's score). Hence the clinical and symptomatic improvement of the patient's lesion was expressed by the numerical difference between baseline and endpoint scores. 14 Pain was recorded using the Visual Analogue Scale (VAS), which consisted of a 10-cm horizontal line, starting from 0 (designating no pain experienced by the patient to 10 (designating unbearable or most severe pain). Pain and RAE records were taken before treatment, after treatment and then after 2 months follow up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Lichen Planus

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    comparison group (active control)
    Arm Type
    Active Comparator
    Arm Description
    0.1 % topical triamcinolone acetonide preparation (Kenacourt-A Orabase Pomad, DEVA HOLDINGS A.S., Istanbul, Turkey) was used where the patients' were instructed to apply the gel 4 times daily, with no food or fluid taken one hour after application. Patients used the medication for 4 weeks , and if extension of treatment was required after that period , patients were instructed to apply miconazole oral gel (JANSSEN-CILAG Pty Ltd 1-5 Khartoum Road North Ryde NSW 2113 Australia) four times a day for one week to protect from superimposed fungal infections.15
    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    OLP lesions were irradiated with a 970-nm diode laser (SIRO Laser Advance class III b, SIRONA, Germany) with a 2 W irradiation power in a continuous non-contact mode. The laser beam was delivered using a fiber-optic tip with a 320 µm diameter with defocused mode directed at the lesions plus 0.5 cm peri- lesional tissues with a slight overlapping in order to evenly distribute energy covering all the lesional and peri-lesional tissues until blanching of the area was observed.14 Diode laser was calibrated to an output power of 3W, frequency of 30 Hz, energy of 180 joule and time interval of 8 minutes divided into 4 sessions , two min each with one minute rest in between to allow for tissue relaxation. Irradiation was done twice weekly for two months until the resolution of signs for a maximum of ten sessions.11 After each session, patients were advised to have a cold diet and use chlorhexidine oral gel postoperatively twice a day to the lesion for one week.
    Intervention Type
    Drug
    Intervention Name(s)
    0.1 % topical triamcinolone acetonide
    Intervention Description
    0.1 % topical triamcinolone acetonide preparation was used where the patients' were instructed to apply the gel 4 times daily, with no food or fluid taken one hour after application.
    Intervention Type
    Device
    Intervention Name(s)
    SIROIaser
    Intervention Description
    Oral Lichen Planus lesions were irradiated with a 970-nm diode laser with a 2 W irradiation power in a continuous non-contact mode. The laser beam was delivered using a fiber-optic tip with a 320 µm diameter with defocused mode directed at the lesions plus 0.5 cm peri- lesional tissues with a slight overlapping in order to evenly distribute energy covering all the lesional and peri-lesional tissues until blanching of the area was observed.14 Diode laser was calibrated to an output power of 3W, frequency of 30 Hz, energy of 180 joule and time interval of 8 minutes divided into 4 sessions , two min each with one minute rest in between to allow for tissue relaxation. Irradiation was done twice weekly (once every third day) for two months until the resolution of signs for a maximum of ten sessions.
    Primary Outcome Measure Information:
    Title
    change in VAS
    Description
    Visual Analogue Scale (VAS) The pain VAS is a continuous single-item scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme Range: 0-10 (cm) no pain (0-0.4 cm), mild pain (0.55-4.4 cm), moderate pain (4.5-7.4)cm, and severe pain (7.5- 10) cm A higher score indicates greater pain intensity
    Time Frame
    two months
    Secondary Outcome Measure Information:
    Title
    change in RAE
    Description
    The Reticular, Atrohpic, Erosive ( RAE ) scale used by Thongprasom and co-workers records and measures the clinical appearance of the Oral Lichen Planus) OLP lesion Score range: 0-5 with o being the most favorable clinical appearance and 5 the most severe clinical appearance. score 0: no lesions; score 1: hyperkeratotic lesions score 2: atrophic area ≤1 cm2 score 3: atrophic area >1 cm2 score 4: erosive area ≤1 cm2 score 5: erosive area >1 cm2
    Time Frame
    two months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    62 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: histological diagnosis of OLP on the basis of WHO criteria (Meji and van der Waal 2003). presence of painful and atrophic-erosive oral lesions, unresponsive to topical corticosteroid therapy ability to complete the present clinical trial. Exclusion Criteria: Presence of histological signs of dysplasia use of lichenoid reaction inducing drugs Therapy for OLP in the 2 months prior to the study; Patients suffering from any disease that may present with features similar to OLP (graft versus host disease or lupus erythematosus) Pregnant or lactating females Patients with uncontrolled diabetes or hypertension, positive HCV Ab or HBs Ag. Smokers

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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