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Completed

NCT Number: NCT02744378

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

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

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Key information

Conditions

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

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tacrolimus 0.1%

Drug

This group was randomly allocated to receive topical Tacrolimus 0.1% for 3 consecutive weeks

Clobetasol 0.05%

Drug

This group was randomly allocated to receive topical Clobetasol 0.05% for 3 consecutive weeks

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Peradeniya

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 20, 2016
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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