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

NCT02744378 | Completed Phase 2

• 1 other identifier: RG/2013/08/D
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Oral Lichen Planus

Outcome Measures

Primary Outcomes (2)

• 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 \<VAS≤7, Scale 3: severe pain: 7\< VAS≤10.

  Three weeks after the application of drugs

• 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

Study Arms (2)

Clobetasol Group

ACTIVE COMPARATOR

clobetasol propionate (0.05%) cream

Drug: Clobetasol 0.05%

Tacrolimus Group

ACTIVE COMPARATOR

tacrolimus (0.1%) cream

Drug: Tacrolimus 0.1%

Interventions

Tacrolimus 0.1% DRUG

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

Tacrolimus Group

Clobetasol 0.05% DRUG

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

Clobetasol Group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically and Histologically proven Oral Lichen Planus
• Symptomatic

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Peradeniya: lead

MeSH Terms

Conditions

Lichen Planus, Oral

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 20, 2016
• Study Start: June 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 20, 2016

Record last verified: 2016-04