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Comparison of Tacrolimus 0.1% and Clobetasol 0.05% in the Management of Symptomatic Oral Lichen Planus

Primary Purpose

Oral Lichen Planus

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tacrolimus 0.1%
Clobetasol 0.05%
Sponsored by
University of Peradeniya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Lichen Planus

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinically and Histologically proven Oral Lichen Planus
  • Symptomatic

Exclusion Criteria:

  • topical/ systemic medication for OLP in the previous three months
  • contraindication for medications use such as a history of allergy to either corticosteroids/ tacrolimus
  • immunosuppression, or pregnant / lactating females
  • lichenoid reactions either drug induced or due to dental amalgam
  • diabetes mellitus and on oral hypoglycemic drugs
  • systemic involvement such as concurrent skin/genital lesions

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Clobetasol Group

    Tacrolimus Group

    Arm Description

    clobetasol propionate (0.05%) cream

    tacrolimus (0.1%) cream

    Outcomes

    Primary Outcome Measures

    The intensity of Pain
    The intensity of pain was assessed using visual analog scale (VAS) - The patients were asked to score their intensity of pain using a VAS where the pain scores ranged from 0 (no pain) to 10 (extreme pain) Four VAS was recorded one for spicy food and the other one for without spicy food for right side and left sides separately. The mean VAS was calculated for each side and the severity of pain was evaluated according to the following scales: Scale 0: no pain: VAS=0, Scale 1: mild pain: 0< VAS≤3.5, Scale 2: moderate pain: 3.5 <VAS≤7, Scale 3: severe pain: 7< VAS≤10.
    The clinical response
    The clinical response of the lesion was scored according to the grading system formulated by Thongprasom et al.,in 1992 for the mucosal lesions: Score 5 = white striae with erosive area more than 1 cm, Score 4 = white striae with erosive area less than 1 cm, Score 3 = white striae with atrophic area more than 1 cm, Score 2 = white striae with atrophic area less than 1 cm, Score 1 =mild white striae, no erythematous area Score 0 = no lesion, normal mucosa. This scorings were performed for both right and left sides separately.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 6, 2016
    Last Updated
    April 19, 2016
    Sponsor
    University of Peradeniya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02744378
    Brief Title
    Comparison of Tacrolimus 0.1% and Clobetasol 0.05% in the Management of Symptomatic Oral Lichen Planus
    Official Title
    Comparison of Tacrolimus 0.1% and Clobetasol 0.05% in the Management of Symptomatic Oral Lichen Planus- A Double-blinded Randomized Clinical Trial in Sri Lanka
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Peradeniya

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This clinical study is carried out to assess the efficacy of Tacrolimus and Clobetasol in symptomatic Oral Lichen Planus.

    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
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    68 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Clobetasol Group
    Arm Type
    Active Comparator
    Arm Description
    clobetasol propionate (0.05%) cream
    Arm Title
    Tacrolimus Group
    Arm Type
    Active Comparator
    Arm Description
    tacrolimus (0.1%) cream
    Intervention Type
    Drug
    Intervention Name(s)
    Tacrolimus 0.1%
    Intervention Description
    This group was randomly allocated to receive topical Tacrolimus 0.1% for 3 consecutive weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Clobetasol 0.05%
    Intervention Description
    This group was randomly allocated to receive topical Clobetasol 0.05% for 3 consecutive weeks
    Primary Outcome Measure Information:
    Title
    The intensity of Pain
    Description
    The intensity of pain was assessed using visual analog scale (VAS) - The patients were asked to score their intensity of pain using a VAS where the pain scores ranged from 0 (no pain) to 10 (extreme pain) Four VAS was recorded one for spicy food and the other one for without spicy food for right side and left sides separately. The mean VAS was calculated for each side and the severity of pain was evaluated according to the following scales: Scale 0: no pain: VAS=0, Scale 1: mild pain: 0< VAS≤3.5, Scale 2: moderate pain: 3.5 <VAS≤7, Scale 3: severe pain: 7< VAS≤10.
    Time Frame
    Three weeks after the application of drugs
    Title
    The clinical response
    Description
    The clinical response of the lesion was scored according to the grading system formulated by Thongprasom et al.,in 1992 for the mucosal lesions: Score 5 = white striae with erosive area more than 1 cm, Score 4 = white striae with erosive area less than 1 cm, Score 3 = white striae with atrophic area more than 1 cm, Score 2 = white striae with atrophic area less than 1 cm, Score 1 =mild white striae, no erythematous area Score 0 = no lesion, normal mucosa. This scorings were performed for both right and left sides separately.
    Time Frame
    Three weeks after the application of drugs

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinically and Histologically proven Oral Lichen Planus Symptomatic Exclusion Criteria: topical/ systemic medication for OLP in the previous three months contraindication for medications use such as a history of allergy to either corticosteroids/ tacrolimus immunosuppression, or pregnant / lactating females lichenoid reactions either drug induced or due to dental amalgam diabetes mellitus and on oral hypoglycemic drugs systemic involvement such as concurrent skin/genital lesions

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Tacrolimus 0.1% and Clobetasol 0.05% in the Management of Symptomatic Oral Lichen Planus

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