Clinical and Immunohistochemical Effect of Topical Pimecrolimus in Treatment of Oral Lichen Planus

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Pimecrolimus; Tacrolimus

Criteria

Inclusion Criteria:

• clinically and histologically confirmed painful Erosive or Atrophic OLP

• free from any systemic diseases using medical questionnaire guided by Cornell Medical Index

Exclusion Criteria:

• history of drug induced lichenoid lesions

• potential treatment of OLP for less than 2 weeks by topical and 4 weeks systemic therapy before study start

• pregnant or breast-feeding women,

• smoking and

• known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation

• loss of paliability or flexibility in the tissues involved by the oral lesions or histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites.