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Tacrolimus for Malar Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03715387
Recruitment Status : Unknown
Verified October 2018 by Richard Warren, University of British Columbia.
Recruitment status was:  Recruiting
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Information provided by (Responsible Party):
Richard Warren, University of British Columbia

Brief 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.

Condition or disease Intervention/treatment Phase
Edema Face Drug: Tacrolimus Topical 0.1% Topical Ointment Drug: Polysporin Ointment Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Patients will serve as their own self matched controls with one study cheek and one control cheek.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Patients will receive a container for each cheek where the contents will be randomized between the study ointment and the control ointment. Only one investigator will have knowledge of the contents. The care providor, patient, and assessor will all be blinded.
Primary Purpose: Prevention
Official Title: Malar Bags After Lower Lid Blepharoplasty and Facelift: A Randomized Controlled Trial of the Effects of Tacrolimus
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: Tacrolimus Treatment
Tacrolimus Topical 0.1% Topical Ointment
Drug: Tacrolimus Topical 0.1% Topical Ointment
Topical tacrolimus ointment
Other Name: Protopic

Placebo Comparator: Control
Patients will be self matched controls with one cheek receiving the study ointment and the other receiving a control ointment (polysporin ointment).
Drug: Polysporin Ointment
Polysporin ointment
Other Name: Polysporin

Primary Outcome Measures :
  1. Malar edema [ Time Frame: 6 months ]
    Development of malar edema post operatively

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03715387

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Contact: Richard Warren, MD 604-876-1774
Contact: Tracy Stuby 604-876-1774

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Canada, British Columbia
Vancouver Plastic Surgery Center Recruiting
Vancouver, British Columbia, Canada, V5Z 4J7
Contact: Richard Warren, MD    604-876-1774      
Contact: Tracy Stuby         
Sponsors and Collaborators
University of British Columbia
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Principal Investigator: Richard Warren, MD University of British Columbia
Study Chair: Stahs Pripotnev, MD University of British Columbia

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Responsible Party: Richard Warren, Principal Investigator, University of British Columbia Identifier: NCT03715387    
Other Study ID Numbers: H17-02969
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Polymyxin B
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents
Anti-Bacterial Agents