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

Oral Lichen Planus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02744378
• Other study ID #: RG/2013/08/D
• Status: Completed
• Phase: Phase 2
• First received: April 6, 2016
• Last updated: April 19, 2016
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: University of Peradeniya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sri Lanka: University of Peradeniya
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Peradeniya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Three weeks after the application of drugs	No
Primary	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.	Three weeks after the application of drugs	No