A Comparative Clinical and Immunohistochemical Study Between Topical Pimecrolimus and Corticosteroid in Treatment of Oral Lichen Planus

NCT02443311 Phase 4 COMPLETED

Oral lichen planus (OLP) is a chronic disease characterized by periods of remission and relapse. Therapeutic objectives for OLP should be to quickly reduce disease symptoms by targeting pathophysiological pathways, and to provide long-term management by reducing recurrences. Pimecrolimus is a novel topical selective inflammatory cytokine release inhibitor; considering its mechanism of action it is reasonable to theorize that pimecrolimus may effectively treat OLP without the potential side effects that are associated with corticosteroids.

Details

Lead sponsor	Ain Shams University
Phase	Phase 4
Status	COMPLETED
Enrolment	24
Start date	2010-09
Completion	2012-08

Conditions

• Oral Lichen Planus

Interventions

• Pimecrolimus 1% cream
• Betamethasone 17-valerate 0.1% cream

Primary outcomes

• clinical scoring (CS) — 2 months/ once per week for one months then after 2 months
  0 represented no lesion/normal mucosa; 1, mild white striae/no erythematous area; 2, white striae with atrophic area less than 1 cm²; 3, white striae with atrophic area more than 1 cm²; 4, white striae with erosive area less than 1 4 cm²; and 5, white striae with erosive area more than 1 cm²
• visual analog scale (VAS) — 2 months/ once per week for one months then after 2 months
  Patients also ranked the severity of pain and burning sensation on 100-mm visual analog scale