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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2015

Interventions

  • Drug: Tacrolimus 0.1%
    • This group was randomly allocated to receive topical Tacrolimus 0.1% for 3 consecutive weeks
  • Drug: Clobetasol 0.05%
    • This group was randomly allocated to receive topical Clobetasol 0.05% for 3 consecutive weeks

Arms, Groups and Cohorts

  • Active Comparator: Clobetasol Group
    • clobetasol propionate (0.05%) cream
  • Active Comparator: Tacrolimus Group
    • tacrolimus (0.1%) cream

Clinical Trial Outcome Measures

Primary Measures

  • The intensity of Pain
    • Time Frame: Three weeks after the application of drugs
    • 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
    • Time Frame: Three weeks after the application of drugs
    • 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.

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 20 Years

    Maximum Age: 70 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • University of Peradeniya
    • Provider of Information About this Clinical Study
      • Principal Investigator: Dr. P.V.K.S Hettiarachchi, Dr – University of Peradeniya

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