Mohs Surgery
Conditions
Brief summary
This study will evaluate the safety and efficacy of EB-001 in improving wound healing and reducing scar formation in patients undergoing Mohs surgery for skin lesions in the forehead area following a single treatment of EB-001 when injected into the muscles underlying the incision area.
Detailed description
This study will evaluate the safety and efficacy of EB-001 in improving wound healing and reducing scar formation in patients undergoing Mohs surgery for skin lesions in the forehead area following a single treatment of EB-001 when injected into the muscles underlying the incision area. The safety objective is to determine the safety and tolerability of single treatment of EB-001 when injected into facial muscles underlying a surgical wound during Mohs surgery. The efficacy objective is to evaluate the efficacy of a single treatment of EB-001 when injected into the facial muscles (frontalis) underlying the surgical wound in improving wound healing, and reducing scar formation.
Interventions
DRUGEB-001
Injection of EB-001 into area of scarring (forehead)
DRUG0.9% Sodium Chloride Injection
Injection of Saline into area of scarring (forehead)
Sponsors
Bonti, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Between 18 and 75 years of age, inclusive 2. Subject in good health, or with stable treated medical condition, as determined by the investigator. 3. Scheduled to undergo Mohs surgery to remove a single skin lesion in the forehead. This could be 1. Basal Cell Carcinoma 2. Squamous Cell Carcinoma (non-metastatic) 3. Other suitable lesions according to the investigator opinion 4. Lesion closure size at least 2 cm in length 5. Women of non-childbearing potential must be postmenopausal (at least 12 consecutive months of amenorrhea) 6. Women of childbearing potential must not be pregnant, lactating, or planning to become pregnant during the study 7. Women of childbearing potential agreeing to use either 1. a highly effective method of contraception with failures rates less than 1% per year such as implant, intrauterine device (IUD), or sterilization from the day of dosing for 3 months (subjects who underwent sterilization must have initiated the procedure at least 3 months prior to the day of dosing) or 2. dual methods of contraception with overall failures rates less than 1% per year such as injectable, pill, patch, ring, and diaphragm from the day of dosing for 3 months (subjects using oral contraception must have initiated treatment at least 2 months prior to the day of dosing) 8. Willing and able to complete and comply with procedures, protocol requirements and instructions, which includes completion of all required visits 9. Willing and able to sign and date IRB-approved informed consent 10. Able to speak, read, and understand the language of the informed consent form (ICF) and study questionnaires
Exclusion criteria
1. Pregnant or breast feeding, or planning a pregnancy 2. Body weight less than 50 kg (110 pounds) 3. Reported use of any botulinum toxin of any serotype within last 6 months before study drug administration 4. Anticipated use of any botulinum toxin of any serotype during the study 5. Known hypersensitivity to any botulinum toxin serotype 6. Known allergy or sensitivity to any of the components of the study treatments, or any materials used in the study procedures 7. Aminoglycoside intake within 48 hours prior to or during surgery 8. Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral Sclerosis) 9. Any uncontrolled medical condition that in opinion of investigator, puts subject at undue safety risk 10. Any clinically significant psychiatric condition that, in opinion of investigator, may interfere with study assessments or protocol compliance 11. Any cosmetic procedure, laser resurfacing treatment, or retinoid therapy in the forehead area in the past 30 days before study drug administration 12. Any eyebrow or eyelid ptosis at baseline as determined by the Investigator 13. History of hypertrophic scars or keloid formation or other wound abnormalities as assessed by the investigator 14. History of alcohol or drug abuse in the last 3 years, based on investigator judgement 15. User or former user of nicotine-containing products, as follows: 1. including but not limited to cigarettes, cigars, and chewing or dipping tobacco) who stopped use or consumption (i.e., smoking, chewing, or pinching) of these nicotine-containing products less than 1 year before study drug administration, or 2. topical or oral nicotine preparations for smoking cessation within the past 90 days before study drug administration 16. Anticipated need for surgery or overnight hospitalization during the study 17. Current enrollment in an investigational drug or device study or participation in such a study within 30 days or 5 half-lives of the drug, whichever is longer, of entry into this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Visual Analog Scale (VAS) Change (Values From 0 (Worst) to 10 (Best)) | Day 30 | Assessment of change in Visual Analog Scale score (values from 0 (worst) to 10 (best)) from day of surgery to Day 30. Percentage of subjects reporting an improvement in Visual Analog Scale score. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo 0.9% Sodium Chloride Injection: Single Injection of Saline into area of scarring (forehead) | 4 |
| EB001 EB-001: Single Injection (0.5mL total) of EB-001 into area of scarring (forehead) | 8 |
| Total | 12 |
Baseline characteristics
| Characteristic | Placebo | EB001 | Total |
|---|---|---|---|
| Age, Continuous | 67 years | 59 years | 62 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 8 Participants | 12 Participants |
| Region of Enrollment United States | 4 Participants | 8 Participants | 12 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 7 Participants |
| Weight | 87.28 kg STANDARD_DEVIATION 25.528 | 79.94 kg STANDARD_DEVIATION 19.352 | 82.38 kg STANDARD_DEVIATION 21.055 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 8 |
| other Total, other adverse events | 0 / 4 | 1 / 8 |
| serious Total, serious adverse events | 0 / 4 | 0 / 8 |
Outcome results
Primary
Assessment of Visual Analog Scale (VAS) Change (Values From 0 (Worst) to 10 (Best))
Assessment of change in Visual Analog Scale score (values from 0 (worst) to 10 (best)) from day of surgery to Day 30. Percentage of subjects reporting an improvement in Visual Analog Scale score.
Time frame: Day 30
Population: mITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Assessment of Visual Analog Scale (VAS) Change (Values From 0 (Worst) to 10 (Best)) | 0 Percentage reporting improvement |
| EB001 | Assessment of Visual Analog Scale (VAS) Change (Values From 0 (Worst) to 10 (Best)) | 50 Percentage reporting improvement |