Oral Lichen Planus
Conditions
Brief summary
This clinical study is carried out to assess the efficacy of Tacrolimus and Clobetasol in symptomatic Oral Lichen Planus.
Interventions
DRUGTacrolimus 0.1%
This group was randomly allocated to receive topical Tacrolimus 0.1% for 3 consecutive weeks
DRUGClobetasol 0.05%
This group was randomly allocated to receive topical Clobetasol 0.05% for 3 consecutive weeks
Sponsors
University of Peradeniya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The intensity of Pain | 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. |
| The clinical response | 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. |
Outcome results
None listed