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

University of Peradeniya

Status and phase: Completed; Phase 2

Conditions: Oral Lichen Planus

Treatments: Drug: Tacrolimus 0.1%; Drug: Clobetasol 0.05%

Study type: Interventional

Funder types: Other

Identifiers

NCT02744378

RG/2013/08/D

Details and patient eligibility

About

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

Enrollment: 68 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups

Clobetasol Group

Active Comparator group

Description:

clobetasol propionate (0.05%) cream

Treatment:

Drug: Clobetasol 0.05%

Tacrolimus Group

Active Comparator group

Description:

tacrolimus (0.1%) cream

Treatment:

Drug: Tacrolimus 0.1%