Forehead Scars Following Mohs Micrographic Surgery and Reconstruction for Skin Cancer
Conditions
Scar
Conditions: official terms
Skin Neoplasms
Conditions: Keywords
Scar, Forehead, Skin Cancer, MOHS Surgery, Dermatology
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention
Name: Dysport (abobotulinumtoxinA) Type: Drug
Name: Bacteriostatic 0.9% Sodium Chloride (vehicle) Type: Drug
Overall Status
Recruiting
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
Detailed Description
- 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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Locations
AboutSkin Dermatology and DermSurgery
Englewood, Colorado, United States
Status: Recruiting
Contact: Jessica Sussman - 303-756-7546 - research@aboutskinderm.com
University of California, Irvine: Department of Dermatology
Cleveland, Ohio, United States
Status: Recruiting
Contact: Kristen Doud, CCRP - 216-983-0861 - kristen.doud@uhhospitals.org
Start Date
September 2011
Completion Date
June 2013
Sponsors
AboutSkin Dermatology and DermSurgery, PC
Source
AboutSkin Dermatology and DermSurgery, PC
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page