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Scar | Forehead Scars Following Mohs Micrographic Surgery and Reconstruction for Skin Cancer

Scar research study

What is the primary objective of this study?

This study will test if the use of DysportTM (abobotulinumtoxinA) improves wound healing and scarring after Mohs surgery. Research in the laboratory as well as previous studies in humans have shown improved wound healing and scarring with the use of a similar medication called Botox. Dysport may improve wound healing and scarring by relaxing facial muscles and therefore minimizes the muscle tension and possibly the inflammation around the wound.

Who is eligible to participate?

Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for enrollment: - Ability to understand the risks, benefits, and alternative to participation and give informed consent - Have biopsy proven skin cancer on the medial forehead that is amenable to Mohs surgery. Medial forehead is defined as the area superiorly from the hairline, inferiorly at the eyebrow, and laterally to the tip of the lateral brow (see diagram). - 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, no potential for pregnancy, or if of child-bearing age, must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for 30 days after the last dose of study drug. A negative urine pregnancy test is required at study entry for female subjects of childbearing potential: a woman is considered to be of child bearing potential unless she has had a tubal ligation, total hysterectomy, bilateral oopherectomy, or is postmenopausal (without a menstrual period for at least one year) - Agrees to not use disallowed concomitant medications (retinoids) Exclusion Criteria: The presence of any of the following will exclude a patient from study enrollment. - Pregnant women, women who are breastfeeding, or women of child bearing age who are unwilling to use adequate contraception (described above) during the study period - Current or past history of a neuromuscular disease (such as myasthenia gravis, amyotrophic lateral sclerosis, Eaton-Lambert syndrome) - Currently taking aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents) - History of radiation therapy or chemotherapy - History of keloid or other hypertrophic scar formation - Current or past history of scleroderma - Has used botulinum toxin in the forehead area within one year. - Has significant resting eyebrow ptosis - Has used any topical retinoids to the forehead area within the past 4 weeks - Undergo any scar revision procedure for the duration of the study including intralesional kenalog, laser treatment, and/or scar revision surgeries - Any hypersensitivity to any component of abobotulinumtoxinA (i.e. cow milk protein) or any previous hypersensitivity to any botulinum toxin A or related product. - Non-English speaking: These patients are excluded since translation of the informed consent into other languages is time-consuming and expensive as it requires a bona fide translator for the particular language of interest and this type of person may be difficult to locate. - House staff and students, medical students on a clerkship, and employees related to study personnel or who work for any study personnel, and members of the study team are not eligible to participate in this study as a subject. - The investigator feels that for any reason the subject is not eligible to participate in the study

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Scar

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Dysport (abobotulinumtoxinA)Intramuscular injection effects lasting up to 3 months

Drug:Bacteriostatic 0.9% Sodium Chloride (vehicle)Intramuscular injection

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Dysport (abobotulinumtoxinA)Each patient will be able to receive up to 120 units of Dysport/placebo at the initial visit to treat the entire forehead area (the frontalis, procerus, and corrugator muscles) to insure cosmetic symmetry. Injections will be placed a minimum of 1.5cm above the orbital rim at the mid papillary line to minimize the risk of lid ptosis. The actual amount to be injected will be at the discretion of the Mohs surgeon based on his or her opinion of what amount is needed for sufficient wound paralysis and cosmetic symmetry.

Placebo

Study Status

Recruiting

Start Date: September 2011

Completed Date: June 2019

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Visual Analogue Scale (VAS)

Secondary Outcome: Patient and Observer Assessment Scale (POSAS)

Study sponsors, principal investigator, and references

Principal Investigator: Margaret Mann, MD

Lead Sponsor: University Hospitals Cleveland Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01459666

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