Evaluate Safety and Efficacy of a Single Treatment Cycle of EB-001 in Subjects With Glabellar Frown Lines
Condition: Glabellar Frown Lines (GL)
Intervention: EB-001 injection; Placebo injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To evaluate the safety and efficacy of EB-001 compared to placebo in subjects with glabellar
      frown lines (GL).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed and dated IRB-approved informed consent form (ICF).

          2. Men or women between the ages of 18 and 60, inclusive.

          3. Subjects in good health as determined by medical history, physical and focused
             neurological examinations, clinical laboratory studies, electrocardiograms (ECGs),
             vital signs, and Investigator's judgement.

          4. Presence of bilaterally symmetrical GL of moderate to severe rating at maximum frown,
             as measured using FWS by both the Investigator and subject prior to study treatment.

          5. Subjects with sufficient visual acuity without the use of eyeglasses (contact lens use
             acceptable) to accurately assess their facial wrinkles as determined by Investigator's
             judgement.

          6. Women of child bearing potential must not be pregnant, lactating, or planning to
             become pregnant during the study.

          7. Women of non-childbearing potential must be either postmenopausal (at least 12
             consecutive months of amenorrhea) or surgically sterile (e.g., tubal ligation,
             hysterectomy, etc.).

          8. Women of childbearing potential agreeing to use dual methods of contraception from the
             day of dosing until 3 months afterwards. Female subjects using oral contraception must
             have initiated treatment at least 2 months prior to the day of dosing.

          9. Male subjects with partner(s) of childbearing potential agreeing to use dual methods
             of contraception from the day of dosing until 3 months afterwards, and to no sperm
             donation from day of dosing until 3 months afterwards.

         10. Willing and able to complete protocol requirements and instructions, which include
             completion of all required visits.

        Exclusion Criteria:

          1. Any condition that precludes a subject's ability to comply with study requirements,
             including completion of the study visits or inability to read, understand, and/or
             self-assess GL severity using FWS.

          2. Any uncontrolled systemic disease or other medical condition.

          3. Any medical condition that may put the subject at increased risk with exposure to
             botulinum toxin of any serotype, including diagnosed myasthenia gravis, Eaton-Lambert
             syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere
             with neuromuscular function.

          4. Current or previous botulinum toxin treatment of any serotype.

          5. Anticipated need for treatment with botulinum toxin of any serotype for any reason
             during the study (other than study treatment).

          6. Known immunization or hypersensitivity to any botulinum toxin serotype.

          7. Known allergy or sensitivity to any of the components of the study treatments, or any
             materials used in the study procedures.

          8. Any of the following procedures or treatments occurring within the specified period
             prior to screening:

               -  3 months: Non-ablative resurfacing laser or light treatment, microdermabrasion,
                  or superficial peels.

               -  6 months: Any facial cosmetic procedure with medium depth to deep facial chemical
                  peels (e.g., trichloroacetic acid [TCA] and phenol), or mid facial or periorbital
                  laser skin resurfacing.

               -  6 months: On topical retinoid therapy and/or topical hormone cream applied to the
                  face, who have not been on a consistent dose regimen and are unable to maintain
                  the same regimen for the study.

               -  12 months: Mid-facial or periorbital treatment with non-permanent soft tissue
                  fillers.

               -  12 months: On oral retinoid therapy.

          9. Prior periorbital surgery, facial lift (full face or mid face), brow lift, or related
             procedures (e.g., eyelid [blepharoplasty] and/or eyebrow surgery).

         10. Prior mid face or periorbital treatment with permanent soft tissue fillers, synthetic
             implantation (e.g., Gore-Tex®), and/or autologous fat transplantation.

         11. Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick
             sebaceous skin.

         12. The inability to substantially lessen facial rhytides (fixed lines) even by physically
             spreading them apart, as determined by the Investigator.

         13. Permanent make-up that would interfere with the assessment of facial wrinkles.

         14. Subjects who, in the Investigator's opinion, are unable or unwilling to maintain their
             standardized skin care regimen throughout the study period.

         15. Any eyebrow or eyelid ptosis at baseline as determined by the Investigator.

         16. Infection or skin disorder at the injection sites.

         17. History of facial nerve palsy.

         18. Recent history (within 6 months of screening) of alcohol or drug abuse based on the
             Investigator's judgement.

         19. 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.