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

NCT02939326 | Completed Phase 2 Results

• 1 other identifier: EB001-GL201
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Glabellar Frown Lines (GL)

Outcome Measures

Primary Outcomes (1)

• Investigator's Assessment of GL Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS).

  Subjects Achieving a 2 Grade Response At Maximum Frown On Any Study Day By Dose using the Facial Wrinkle Scale (FWS) The FWS is a four-point scale that indicates severity of GL as follows: 0 = none, 1 = mild, 2 = moderate, or 3 = severe. Each scale is a four-point photonumeric scale based on photographs incorporating each aspect to be evaluated in a stepwise manner.

  After single injection treatment up to 42 days

Study Arms (8)

Placebo

PLACEBO COMPARATOR

Intervention: Drug: Placebo Single Injection of placebo into five (5) 0.1 mL IM injections into glabellar area.

Drug: Placebo injection

EB-001 Dose 1 (1X)

ACTIVE COMPARATOR

Intervention: Drug: EB-001 Single Injection of Low Dose of EB-001 into five (5) 0.1 mL IM Injections into glabellar area

Drug: EB-001 injection

EB-001 Dose 2 (3X)

ACTIVE COMPARATOR

Intervention: Drug: EB-001, 3X Dose 1 Single Injection of EB-001 into five (5) 0.1 mL IM Injections into glabellar area

Drug: EB-001 injection

EB-001 Dose 3 (9X)

ACTIVE COMPARATOR

Intervention: Drug: EB-001, 9X Dose 1 Single Injection of EB-001 into five (5) 0.1 mL IM Injections into glabellar area

Drug: EB-001 injection

EB-001 Dose 4 (12X)

ACTIVE COMPARATOR

Intervention: Drug: EB-001, 12X Dose 1 Single Injection of EB-001 into five (5) 0.1 mL IM Injections into glabellar area

Drug: EB-001 injection

EB-001 Dose 5 (16X)

ACTIVE COMPARATOR

Intervention: Drug: EB-001, 16X Dose 1 Single Injection of EB-001 into five (5) 0.1 mL IM Injections into glabellar area

Drug: EB-001 injection

EB-001 Dose 6 (21X)

ACTIVE COMPARATOR

Intervention: Drug: EB-001, 21X Dose 1 Single Injection of EB-001 into five (5) 0.1 mL IM Injections into glabellar area

Drug: EB-001 injection

EB-001 Dose 7 (28X)

ACTIVE COMPARATOR

Intervention: Drug: EB-001, 28X Dose 1 Single Injection of Highest Dose of EB-001 into five (5) 0.1 mL IM Injections into glabellar area

Drug: EB-001 injection

Interventions

EB-001 injection DRUG

Also known as: Botulinun Toxin Type E

EB-001 Dose 1 (1X); EB-001 Dose 2 (3X); EB-001 Dose 3 (9X); EB-001 Dose 4 (12X); EB-001 Dose 5 (16X); EB-001 Dose 6 (21X); EB-001 Dose 7 (28X)

Placebo injection DRUG

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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:
• months: Non-ablative resurfacing laser or light treatment, microdermabrasion, or superficial peels.
• 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.
• 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.
• months: Mid-facial or periorbital treatment with non-permanent soft tissue fillers.
• 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.

Sponsors & Collaborators

• Bonti, Inc.: lead

Study Sites (2)

Center For Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

Location

Steve Yoelin, MD Medical Associates, INC.

Newport Beach, California, 92663, United States

Location

Related Publications (1)

• Yoelin SG, Dhawan SS, Vitarella D, Ahmad W, Hasan F, Abushakra S. Safety and Efficacy of EB-001, a Novel Type E Botulinum Toxin, in Subjects with Glabellar Frown Lines: Results of a Phase 2, Randomized, Placebo-Controlled, Ascending-Dose Study. Plast Reconstr Surg. 2018 Dec;142(6):847e-855e. doi: 10.1097/PRS.0000000000005029.

  PMID: 30489516 DERIVED

Results Point of Contact

• Title: Wajdie Ahmad
• Organization: Bonti

wajdie@bonti.com

9493796569

Study Officials

• Earvin Liang

  Bonti, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: October 20, 2016
• Study Start: December 1, 2016
• Primary Completion: July 12, 2017
• Study Completion: July 12, 2017
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2019-01

Locations

US (2)