Phase 2
N=42
Evaluate Safety and Efficacy of a Single Treatment Cycle of EB-001 in Subjects With Glabellar Frown Lines
Glabellar Frown Lines (GL)
Bottom Line
View on ClinicalTrials.gov: NCT02939326 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Investigator's Assessment of GL Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS). — 1; 0; 0; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- EB-001 injection (Drug); Placebo injection (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bonti, Inc.
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigator's Assessment of GL Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS). |
1; 0; 0; 2; 3; 2 | — |
Summary
To evaluate the safety and efficacy of EB-001 compared to placebo in subjects with glabellar frown lines (GL).
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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'
Data sourced from ClinicalTrials.gov (NCT02939326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.