Forehead Scars Following Mohs Micrographic Surgery and Reconstruction for Skin Cancer
This study is currently recruiting participants.
Verified January 2012 by AboutSkin Dermatology and DermSurgery, PC
Sponsor:
AboutSkin Dermatology and DermSurgery, PC
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
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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
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 May 19, 2013