Study of EB-001 in Facial Scar Reduction
Condition: Mohs Surgery
Intervention: EB-001; 0.9% Sodium Chloride Injection
Intervention description: Injection of EB-001 into area of scarring (forehead); Injection of Saline into area of scarring (forehead)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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