Tacrolimus for Malar Edema

• Status: Unknown status
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Elective lower eyelid surgery is a common cosmetic procedure. Facial swelling is a common complication. Studies suggest that this facial swelling is part of a complex inflammatory process. Topical tacrolimus has long been used to treat various inflammatory skin disorders. By combining our knowledge of facial swelling and tacrolimus mechanism of action, we can hypothesize that it can be used as a treatment to prevent this post-operative swelling. The purpose of this project is to apply topical tacrolimus to one of the patient's cheeks following facial surgery and compare the incidence of facial swelling to the opposite side control cheek.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of British Columbia
• Treatments: Bacitracin; Gramicidin; Polymyxin B; Tacrolimus

Criteria

Inclusion Criteria:

• Bilateral lower lid blepharoplasty, facelift, or both.

• Patients over 18 years of age.

Exclusion Criteria:

• -Patients presenting for revision surgery.

• Patients with a known allergy to tacrolimus.

• Patients taking medications that alter tacrolimus metabolism:

• Anticonvulsants: carbamazepine, phenobarbital, phenytoin

• Antibiotics: rifampicin, rifabutin

• Antifungal: clotrimazole, ketoconazole, fluconazole, itraconazole

• Ca++ channel blockers: diltiazem, nifedipine, nicardipine, verapamil

• Macrolides: erythromycin, clarithromycin, troleandomycin

• Miscellaneous: cyclosporin A, danazol, bromocriptine, cimetidine, methylprednisolone, protease inhibitors

• Patients with previously diagnosed reduced kidney function.

• Immunocompromised patients.

• Patients with a history of cutaneous facial malignancies.

• Patients with active cutaneous facial infections.