Evaluate Safety and Efficacy of a Single Treatment Cycle of EB-001 in Subjects With Glabellar Frown Lines

Completed · Phase 2 · Has a placebo group

Conditions studied: Glabellar Frown Lines (GL)

In brief

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

Key facts

Study ID

NCT02939326

Run by

Bonti, Inc.

People needed

42

Starts

2016-12-01

Expected to finish

2017-07-12

Last updated by the study team

2019-02-15

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Signed and dated IRB-approved informed consent form (ICF).
• Men or women between the ages of 18 and 60, inclusive.
• 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.
• 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.
• 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.
• Women of child bearing potential must not be pregnant, lactating, or planning to become pregnant during the study.
• 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.).
• 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.
• 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.
• Willing and able to complete protocol requirements and instructions, which include completion of all required visits.

You may not qualify if…

• 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.
• Any uncontrolled systemic disease or other medical condition.
• 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.
• Current or previous botulinum toxin treatment of any serotype.
• Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study treatment).
• Known immunization or 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.
• 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.
• Prior periorbital surgery, facial lift (full face or mid face), brow lift, or related procedures (e.g., eyelid [blepharoplasty] and/or eyebrow surgery).
• Prior mid face or periorbital treatment with permanent soft tissue fillers, synthetic implantation (e.g., Gore-Tex®), and/or autologous fat transplantation.
• Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin.
• The inability to substantially lessen facial rhytides (fixed lines) even by physically spreading them apart, as determined by the Investigator.
• Permanent make-up that would interfere with the assessment of facial wrinkles.
• Subjects who, in the Investigator's opinion, are unable or unwilling to maintain their standardized skin care regimen throughout the study period.
• Any eyebrow or eyelid ptosis at baseline as determined by the Investigator.
• Infection or skin disorder at the injection sites.
• History of facial nerve palsy.
• Recent history (within 6 months of screening) of alcohol or drug abuse based on the Investigator's judgement.
• 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.

Where it is running

• Center For Dermatology Clinical Research, Inc. — Fremont, California, United States
• Steve Yoelin, MD Medical Associates, INC. — Newport Beach, California, United States

Full record on ClinicalTrials.gov

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