CompletedPhase 2

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

United States42 participantsStarted 2016-12

Plain-language summary

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

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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:

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

Timeframe: After single injection treatment up to 42 days

NCT IDNCT02939326

SponsorBonti, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-07-12

Results submitted2018-10-17

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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: