Management of Pain in Oral Lichen Planus

NCT03572959 | Completed Phase 4 FDA Drug FDA Device

• 1 other identifier: 15023
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oral Lichen Planus

Outcome Measures

Primary Outcomes (1)

• 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

  two months

Secondary Outcomes (1)

• change in RAE

  two months

Study Arms (2)

comparison group (active control)

ACTIVE COMPARATOR

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

Drug: 0.1 % topical triamcinolone acetonide

experimental group

EXPERIMENTAL

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.

Device: SIROIaser

Interventions

0.1 % topical triamcinolone acetonide DRUG

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.

comparison group (active control)

SIROIaser DEVICE

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.

experimental group

Eligibility Criteria

• Age: 45 Years - 62 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sherine Adel Nasry: lead

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: June 28, 2018
• Study Start: December 27, 2016
• Primary Completion: March 20, 2017
• Study Completion: May 22, 2017
• Last Updated: July 3, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share