Back to results

Forehead Scars Following Mohs Micrographic Surgery and Reconstruction for Skin Cancer

Primary Purpose

Scar

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Dysport (abobotulinumtoxinA)

Bacteriostatic 0.9% Sodium Chloride (vehicle)

About this trial

This is an interventional treatment trial for Scar focused on measuring Scar, Forehead, Skin Cancer, MOHS Surgery, Dermatology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospitals Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
UH Cleveland Medical Center-Westlake

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dysport (abobotulinumtoxinA)

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient and Observer Assessment Scale (POSAS)

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.

Visual Analogue Scale (VAS)

Evaluate efficacy of using aboBTX-A to improve wound healing prior to Mohs micrographic surgery and reconstruction for skin cancer as measured by the Visual Analogue Scale (VAS)

Full Information

NCT ID

NCT01459666

First Posted

October 18, 2011

Last Updated

April 29, 2022

Sponsor

University Hospitals Cleveland Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01459666

Brief Title

Forehead Scars Following Mohs Micrographic Surgery and Reconstruction for Skin Cancer

Official Title

A Prospective, Multi-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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Terminated

Why Stopped

Investigator left institution for private practice

Study Start Date

September 2011 (undefined)

Primary Completion Date

August 2019 (Actual)

Study Completion Date

August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospitals Cleveland Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Primary Objective: -To evaluate the efficacy of using aboBTX-A to improve wound healing prior to Mohs micrographic surgery and reconstruction for skin cancer as measured by the Visual Analogue Scale (VAS) at 6 weeks post surgery. Secondary Objectives: To evaluate efficacy of using aboBTX-A to improve wound healing prior to Mohs micrographic surgery and reconstruction for skin cancer as measured by the Patient and Observer Assessment Scale (POSAS) at week 1, 6, and 24. To evaluate the efficacy of using aboBTX-A to improve wound healing prior to Mohs micrographic surgery and reconstruction for skin cancer as measured by the Visual Analogue Scale (VAS) at week 1 and 24 post surgery. To evaluate patient satisfaction To evaluate safety (adverse events) This is a 6 month, prospective, multicenter, double-blinded, randomized, placebo-controlled study. A total of 40 male or female healthy volunteers, 20 in each arm, will be enrolled. Up to 10 more patients can be enrolled to account for patient drop-out. Subjects will all undergo Mohs micrographic surgical removal of a skin cancer lesion on the forehead followed by reconstruction. Subjects will be randomized to receive either aboBTX-A injection or placebo injection in the frontalis, procerus, and corrugator muscles prior to reconstruction. Photographs, POSAS, and clinical assessments will be taken immediately after initial wound closure, at 1 week follow-up, at 6 weeks follow-up, and at 6 months follow-up. Adverse events will also be reviewed at each study visit. After the completion of the study, the photographs will be assessed (blinded as to the patient identifiers) using a 10 cm visual analog scale (VAS). The first few photographs will be evaluated by the surgeons together to calibrate the VAS and ensure inter-reliability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Scar

Keywords

Scar, Forehead, Skin Cancer, MOHS Surgery, Dermatology

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dysport (abobotulinumtoxinA)

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Dysport (abobotulinumtoxinA)

Other Intervention Name(s)

AbobotulinumtoxinA, Clostridium botulinum type toxin A toxin-haemagglutinin complex

Intervention Description

Intramuscular injection effects lasting up to 3 months

Intervention Type

Drug

Intervention Name(s)

Bacteriostatic 0.9% Sodium Chloride (vehicle)

Intervention Description

Intramuscular injection

Primary Outcome Measure Information:

Title

Visual Analogue Scale (VAS)

Description

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.

Time Frame

6 weeks post surgery

Secondary Outcome Measure Information:

Title

Patient and Observer Assessment Scale (POSAS)

Description

Time Frame

at week 1, 6, and 24 post surgery

Title

Visual Analogue Scale (VAS)

Description

Evaluate efficacy of using aboBTX-A to improve wound healing prior to Mohs micrographic surgery and reconstruction for skin cancer as measured by the Visual Analogue Scale (VAS)

Time Frame

at week 1 and 24 post surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Margaret Mann, MD

Organizational Affiliation

University Hospitals Cleveland Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

UH Cleveland Medical Center-Westlake

City

Westlake

State/Province

Ohio

ZIP/Postal Code

44145

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Forehead Scars Following Mohs Micrographic Surgery and Reconstruction for Skin Cancer

We'll reach out to this number within 24 hrs