Forehead Scars Following Mohs Micrographic Surgery and Reconstruction for Skin Cancer

NCT01459666 | Terminated Phase 4 Results DMC

• 1 other identifier: CASE1Z12
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Scar

Keywords

Scar; Forehead; Skin Cancer; MOHS Surgery; Dermatology

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  It consists of a 10 point scale to assess global scar assessment. Scar photographic images are assessed by independent physicians, and previous studies have shown very high intrarater consistency.

  6 weeks post surgery

Secondary Outcomes (2)

• Patient and Observer Assessment Scale (POSAS)

  at week 1, 6, and 24 post surgery

• Visual Analogue Scale (VAS)

  at week 1 and 24 post surgery

Study Arms (2)

Dysport (abobotulinumtoxinA)

EXPERIMENTAL

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.

Drug: Dysport (abobotulinumtoxinA)

Placebo

PLACEBO COMPARATOR

Drug: Bacteriostatic 0.9% Sodium Chloride (vehicle)

Interventions

Dysport (abobotulinumtoxinA) DRUG

Intramuscular injection effects lasting up to 3 months

Also known as: AbobotulinumtoxinA, Clostridium botulinum type toxin A toxin-haemagglutinin complex

Dysport (abobotulinumtoxinA)

Bacteriostatic 0.9% Sodium Chloride (vehicle) DRUG

Intramuscular injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (2)

University Hospitals Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

UH Cleveland Medical Center-Westlake

Westlake, Ohio, 44145, United States

Location

MeSH Terms

Conditions

Cicatrix; Skin Neoplasms

Interventions

abobotulinumtoxinA; Sodium Chloride

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Kevin Cooper
• Organization: University Hospitals Cleveland Medical Center

Kevin.Cooper@UHhospitals.org

216-844-3100

Study Officials

• Margaret Mann, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: October 26, 2011
• Study Start: September 1, 2011
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: May 26, 2022
• Results First Posted: May 26, 2022

Record last verified: 2022-04

Locations

US (2)