Forehead Scars Following Mohs Micrographic Surgery and Reconstruction for Skin Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IVSupportive careActive18 and overOtherMann-Cohen Version 2
NCT01459666

Trial Description

Summary

Evaluate the efficacy and safety of using aboBTX-A to improve wound healing prior to Mohs micrographic surgery and reconstruction for skin cancer of the forehead

Further Study Information

  • Outcomes by the Patient and Observer Assessment Scale (POSAS), Visual Analog Scale, and Patient Satisfaction Survey.
  • Study consists of 5 clinic visits over approximately 6 months

Eligibility Criteria

Inclusion Criteria:

  • Have biopsy proven skin cancer on the forehead that is amenable to Mohs surgery
  • Undergoing elective reconstruction of biopsy proven skin cancer that is amenable to Mohs surgery with defect size measuring 1.0 cm or greater
  • If female, not currently pregnant, not currently breastfeeding, no potential for pregnancy, or if of child-bearing age, agrees to using birth control.
  • Agrees to not use disallowed concomitant medications (retinoids) and agrees to use sunscreen in the forehead area for the duration of the study

Exclusion Criteria:

  • Current or past history of a neuromuscular disease (such as myasthenia gravis, amyotrophic lateral sclerosis, Eaton-Lambert syndrome)
  • History of radiation therapy or chemotherapy
  • History of keloid or other hypertrophic scar formation
  • Has used botulinum toxin in the forehead area within one year.
  • Has used any topical retinoids to the forehead area within the past 4 weeks
  • Any hypersensitivity to any component of abobotulinumtoxinA (i.e. cow milk protein) or any previous hypersensitivity to any botulinum toxin A or related product.

Trial Contact Information

Trial Lead Organizations/Sponsors

AboutSkin Dermatology and DermSurgery, PC

  • Case Comprehensive Cancer Center
  • Medicis Pharmaceutical Corporation
Margaret Mann, MD, Principal Investigator
Joel L Cohen, MD, Principal Investigator
Jessica Sussman
Ph: 303-756-7546
Email: research@aboutskinderm.com

Trial Sites

U.S.A.

Colorado
Englewood

AboutSkin Dermatology and DermSurgery, PC

Jessica Sussman
Ph: 303-756-7546
Email: research@aboutskinderm.com

Joel L Cohen, MD
Principal Investigator

Ohio
Cleveland

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Kristen Doud, CCRP
Ph: 216-983-0861
Email: kristen.doud@uhhospitals.org

Margaret Mann, MD
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01459666
ClinicalTrials.gov processed this data on April 09, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.