Study of EB-001 in Facial Scar Reduction

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.

Inclusion criteria

• Between 18 and 75 years of age, inclusive
• Subject in good health, or with stable treated medical condition, as determined by the investigator.
• Scheduled to undergo Mohs surgery to remove a single skin lesion in the forehead. This could be

• Basal Cell Carcinoma
• Squamous Cell Carcinoma (non-metastatic)
• Other suitable lesions according to the investigator opinion
• Lesion closure size at least 2 cm in length
• Women of non-childbearing potential must be postmenopausal (at least 12 consecutive months of amenorrhea)
• Women of childbearing potential must not be pregnant, lactating, or planning to become pregnant during the study
• Women of childbearing potential agreeing to use either

• 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
• 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)
• Willing and able to complete and comply with procedures, protocol requirements and instructions, which includes completion of all required visits
• Willing and able to sign and date IRB-approved informed consent
• Able to speak, read, and understand the language of the informed consent form (ICF) and study questionnaires

Exclusion criteria

• Pregnant or breast feeding, or planning a pregnancy
• Body weight less than 50 kg (110 pounds)
• Reported use of any botulinum toxin of any serotype within last 6 months before study drug administration
• Anticipated use of any botulinum toxin of any serotype during the study
• Known hypersensitivity to any botulinum toxin serotype
• Known allergy or sensitivity to any of the components of the study treatments, or any materials used in the study procedures
• Aminoglycoside intake within 48 hours prior to or during surgery
• Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral Sclerosis)
• Any uncontrolled medical condition that in opinion of investigator, puts subject at undue safety risk
• Any clinically significant psychiatric condition that, in opinion of investigator, may interfere with study assessments or protocol compliance
• Any cosmetic procedure, laser resurfacing treatment, or retinoid therapy in the forehead area in the past 30 days before study drug administration
• Any eyebrow or eyelid ptosis at baseline as determined by the Investigator
• History of hypertrophic scars or keloid formation or other wound abnormalities as assessed by the investigator
• History of alcohol or drug abuse in the last 3 years, based on investigator judgement
• User or former user of nicotine-containing products, as follows:

• 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
• topical or oral nicotine preparations for smoking cessation within the past 90 days before study drug administration
• Anticipated need for surgery or overnight hospitalization during the study
• 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