Forehead Scars Following Mohs Micrographic Surgery and Reconstruction for Skin Cancer
Conditions: official terms
Skin Neoplasms
Conditions: Keywords
Scar, Forehead, Skin Cancer, MOHS Surgery, Dermatology
Study Type
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
Name: Dysport (abobotulinumtoxinA) Type: Drug
Name: Bacteriostatic 0.9% Sodium Chloride (vehicle) Type: Drug
Overall Status
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.
AboutSkin Dermatology and DermSurgery
Englewood, Colorado, United States
Status: Recruiting
Contact: Jessica Sussman - 303-756-7546 -
University of California, Irvine: Department of Dermatology
Cleveland, Ohio, United States
Status: Recruiting
Contact: Kristen Doud, CCRP - 216-983-0861 -
Start Date
September 2011
Completion Date
June 2013
AboutSkin Dermatology and DermSurgery, PC
AboutSkin Dermatology and DermSurgery, PC
Record processing date processed this data on July 28, 2015 page