Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

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

Margaret Mann, MD

Principal Investigator

Joel L Cohen, MD

Principal Investigator

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

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
	University of California, Irvine: Department of Dermatology
		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 Identifer NCT01459666
Information obtained from ClinicalTrials.gov on November 20, 2012

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