Tacrolimus for Malar Edema

NCT03715387 | Unknown Phase 2 DMC

• 1 other identifier: H17-02969
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Edema Face

Outcome Measures

Primary Outcomes (1)

• Malar edema

  Development of malar edema post operatively

  6 months

Study Arms (2)

Tacrolimus Treatment

EXPERIMENTAL

Tacrolimus Topical 0.1% Topical Ointment

Drug: Tacrolimus Topical 0.1% Topical Ointment

Control

PLACEBO COMPARATOR

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

Interventions

Tacrolimus Topical 0.1% Topical Ointment DRUG

Topical tacrolimus ointment

Also known as: Protopic

Tacrolimus Treatment

Polysporin Ointment DRUG

Polysporin ointment

Also known as: Polysporin

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bilateral lower lid blepharoplasty, facelift, or both.
• Patients over 18 years of age.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver Plastic Surgery Center

Vancouver, British Columbia, V5Z 4J7, Canada

RECRUITING

Related Publications (12)

• Pessa JE, Garza JR. The malar septum: the anatomic basis of malar mounds and malar edema. Aesthet Surg J. 1997 Jan-Feb;17(1):11-7. doi: 10.1016/s1090-820x(97)70001-3.

  PMID: 19327681 BACKGROUND

• Nagi KS, Carlson JA, Wladis EJ. Histologic assessment of dermatochalasis: elastolysis and lymphostasis are fundamental and interrelated findings. Ophthalmology. 2011 Jun;118(6):1205-10. doi: 10.1016/j.ophtha.2010.10.013. Epub 2011 Jan 6.

  PMID: 21211847 BACKGROUND

• Nijhawan N, Marriott C, Harvey JT. Lymphatic drainage patterns of the human eyelid: assessed by lymphoscintigraphy. Ophthalmic Plast Reconstr Surg. 2010 Jul-Aug;26(4):281-5. doi: 10.1097/IOP.0b013e3181c32e57.

  PMID: 20551850 BACKGROUND

• Kpodzo DS, Nahai F, McCord CD. Malar mounds and festoons: review of current management. Aesthet Surg J. 2014 Feb;34(2):235-48. doi: 10.1177/1090820X13517897. Epub 2014 Jan 15.

  PMID: 24431347 BACKGROUND

• Cemal Y, Pusic A, Mehrara BJ. Preventative measures for lymphedema: separating fact from fiction. J Am Coll Surg. 2011 Oct;213(4):543-51. doi: 10.1016/j.jamcollsurg.2011.07.001. Epub 2011 Jul 28. No abstract available.

  PMID: 21802319 BACKGROUND

• Ghanta S, Cuzzone DA, Torrisi JS, Albano NJ, Joseph WJ, Savetsky IL, Gardenier JC, Chang D, Zampell JC, Mehrara BJ. Regulation of inflammation and fibrosis by macrophages in lymphedema. Am J Physiol Heart Circ Physiol. 2015 May 1;308(9):H1065-77. doi: 10.1152/ajpheart.00598.2014. Epub 2015 Feb 27.

  PMID: 25724493 BACKGROUND

• Avraham T, Zampell JC, Yan A, Elhadad S, Weitman ES, Rockson SG, Bromberg J, Mehrara BJ. Th2 differentiation is necessary for soft tissue fibrosis and lymphatic dysfunction resulting from lymphedema. FASEB J. 2013 Mar;27(3):1114-26. doi: 10.1096/fj.12-222695. Epub 2012 Nov 27.

  PMID: 23193171 BACKGROUND

• Clavin NW, Avraham T, Fernandez J, Daluvoy SV, Soares MA, Chaudhry A, Mehrara BJ. TGF-beta1 is a negative regulator of lymphatic regeneration during wound repair. Am J Physiol Heart Circ Physiol. 2008 Nov;295(5):H2113-27. doi: 10.1152/ajpheart.00879.2008. Epub 2008 Oct 10.

  PMID: 18849330 BACKGROUND

• Zampell JC, Yan A, Elhadad S, Avraham T, Weitman E, Mehrara BJ. CD4(+) cells regulate fibrosis and lymphangiogenesis in response to lymphatic fluid stasis. PLoS One. 2012;7(11):e49940. doi: 10.1371/journal.pone.0049940. Epub 2012 Nov 20.

  PMID: 23185491 BACKGROUND

• Zhang B, Wang J, Gao J, Guo Y, Chen X, Wang B, Gao J, Rao Z, Chen Z. Alternatively activated RAW264.7 macrophages enhance tumor lymphangiogenesis in mouse lung adenocarcinoma. J Cell Biochem. 2009 May 1;107(1):134-43. doi: 10.1002/jcb.22110.

  PMID: 19241443 BACKGROUND

• Sehgal VN, Srivastava G, Dogra S. Tacrolimus in dermatology-pharmacokinetics, mechanism of action, drug interactions, dosages, and side effects: part I. Skinmed. 2008 Jan-Feb;7(1):27-30. doi: 10.1111/j.1540-9740.2007.06485.x.

  PMID: 18174798 BACKGROUND

• Gardenier JC, Kataru RP, Hespe GE, Savetsky IL, Torrisi JS, Nores GD, Jowhar DK, Nitti MD, Schofield RC, Carlow DC, Mehrara BJ. Topical tacrolimus for the treatment of secondary lymphedema. Nat Commun. 2017 Feb 10;8:14345. doi: 10.1038/ncomms14345.

  PMID: 28186091 BACKGROUND

MeSH Terms

Interventions

Tacrolimus; Ointments; polysporin ointment; bacitracin, polymyxin B drug combination

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Richard Warren, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Stahs Pripotnev, MD

  University of British Columbia

  STUDY CHAIR

Central Study Contacts

Richard Warren, MD

CONTACT

604-876-1774; tracy@drwarren.ca

Tracy Stuby

CONTACT

604-876-1774; tracy@drwarren.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will serve as their own self matched controls with one study cheek and one control cheek.

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 23, 2018
• Study Start: October 10, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: October 23, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)