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Trial record 16 of 18 for:    Atrophic Lichen Planus

Comparison of Tacrolimus 0.1% and Clobetasol 0.05% in the Management of Symptomatic 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. Read our disclaimer for details. Identifier: NCT02744378
Recruitment Status : Completed
First Posted : April 20, 2016
Last Update Posted : April 20, 2016
Information provided by (Responsible Party):
Dr. P.V.K.S Hettiarachchi, University of Peradeniya

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

Condition or disease Intervention/treatment Phase
Oral Lichen Planus Drug: Tacrolimus 0.1% Drug: Clobetasol 0.05% Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Clobetasol Group
clobetasol propionate (0.05%) cream
Drug: Clobetasol 0.05%
This group was randomly allocated to receive topical Clobetasol 0.05% for 3 consecutive weeks

Active Comparator: Tacrolimus Group
tacrolimus (0.1%) cream
Drug: Tacrolimus 0.1%
This group was randomly allocated to receive topical Tacrolimus 0.1% for 3 consecutive weeks

Primary Outcome Measures :
  1. 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.

  2. 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.

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Responsible Party: Dr. P.V.K.S Hettiarachchi, Dr, University of Peradeniya Identifier: NCT02744378     History of Changes
Other Study ID Numbers: RG/2013/08/D
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Lichen Planus, Oral
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists