Forehead Scars Following Mohs Micrographic Surgery and Reconstruction for Skin Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by AboutSkin Dermatology and DermSurgery, PC.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University Hospitals of Cleveland
Medicis Pharmaceutical Corporation
Information provided by (Responsible Party):
AboutSkin Dermatology, AboutSkin Dermatology and DermSurgery, PC
ClinicalTrials.gov Identifier:
NCT01459666
First received: October 18, 2011
Last updated: January 17, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Scar
Drug: Dysport (abobotulinumtoxinA)
Drug: Bacteriostatic 0.9% Sodium Chloride (vehicle)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by AboutSkin Dermatology and DermSurgery, PC:

Primary Outcome Measures:
  • Patient and Observer Assessment Scale (POSAS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: September 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dysport (abobotulinumtoxinA) Drug: Dysport (abobotulinumtoxinA)
Intramuscular injection effects lasting up to 3 months
Placebo Comparator: Placebo Drug: Bacteriostatic 0.9% Sodium Chloride (vehicle)
Intramuscular injection

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459666

Contacts
Contact: Jessica Sussman 303-756-7546 research@aboutskinderm.com

Locations
United States, Colorado
AboutSkin Dermatology and DermSurgery Recruiting
Englewood, Colorado, United States, 80113
Contact: Jessica Sussman    303-756-7546    research@aboutskinderm.com   
Principal Investigator: Joel L Cohen, MD         
United States, Ohio
University of California, Irvine: Department of Dermatology Recruiting
Cleveland, Ohio, United States, 44106
Contact: Kristen Doud, CCRP    216-983-0861    kristen.doud@uhhospitals.org   
Principal Investigator: Margaret Mann, MD         
Sponsors and Collaborators
AboutSkin Dermatology and DermSurgery, PC
University Hospitals of Cleveland
Medicis Pharmaceutical Corporation
Investigators
Principal Investigator: Margaret Mann, MD University Hospitals of Cleveland
Principal Investigator: Joel L Cohen, MD About Skin Dermatology and Dermsurgery
  More Information

No publications provided

Responsible Party: AboutSkin Dermatology, Principal Investigator, Director at AboutSkin Dermatology, AboutSkin Dermatology and DermSurgery, PC
ClinicalTrials.gov Identifier: NCT01459666     History of Changes
Other Study ID Numbers: Mann-Cohen Version 2
Study First Received: October 18, 2011
Last Updated: January 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by AboutSkin Dermatology and DermSurgery, PC:
Scar
Forehead
Skin Cancer
MOHS Surgery
Dermatology

Additional relevant MeSH terms:
Skin Neoplasms
Cicatrix
Neoplasms by Site
Neoplasms
Skin Diseases
Fibrosis
Pathologic Processes
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014