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A Prospective, Dual-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy of abobotulinumtoxinA (BTX-A) in Improving Forehead Wounds After Mohs Micrographic Surgery and Reconstruction for Skin Cancer


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Scar

Thank you

Trial Information

A Prospective, Dual-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy of abobotulinumtoxinA (BTX-A) in Improving Forehead Wounds After Mohs Micrographic Surgery and Reconstruction for Skin Cancer


- 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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Patient and Observer Assessment Scale (POSAS)

Outcome Description:

The Patient and Observer Scar Assessment Scale (POSAS) consists of two numeric scales. One scale is completed by the patients, the other by the clinician. This scale is different than previous scales because it takes the patient's input into consideration. It has good internal consistency and interobserver reliability. The assessment will take place at Day 0, Week 1, Week 6, and Month 6.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Margaret Mann, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospitals of Cleveland

Authority:

United States: Institutional Review Board

Study ID:

Mann-Cohen Version 2

NCT ID:

NCT01459666

Start Date:

September 2011

Completion Date:

June 2013

Related Keywords:

  • Scar
  • Scar
  • Forehead
  • Skin Cancer
  • MOHS Surgery
  • Dermatology
  • Skin Neoplasms
  • Cicatrix

Name

Location

AboutSkin Dermatology and DermSurgeryEnglewood, Colorado  80113
University of California, Irvine: Department of DermatologyCleveland, Ohio  44106