Glabellar Frown Lines (GL)Phase 2NCT02939326
Evaluate Safety and Efficacy of a Single Treatment Cycle of EB-001 in Subjects With Glabellar Frown Lines
A Phase 2 study testing EB-001 injection in people with Glabellar Frown Lines (GL), run by Bonti, Inc. at 2 sites in United States.
Trial summary
To evaluate the safety and efficacy of EB-001 compared to placebo in subjects with glabellar frown lines (GL). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Glabellar Frown Lines (GL)
- What is being tested?
- EB-001 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2016to 12 Jul 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center For Dermatology Clinical Research, Inc.
Fremont, California, 94538
Steve Yoelin, MD Medical Associates, INC.
Newport Beach, California, 92663
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Ascending Dose Cohort Study to Evaluate Safety and Efficacy of a Single Treatment Cycle of EB-001 in Subjects With Glabellar Frown Lines
To evaluate the safety and efficacy of EB-001 compared to placebo in subjects with glabellar frown lines (GL).
Read the detailed description
This study of EB-001 to measure safety and efficacy in GL. Single doses of EB- 001 administered through IM injection into procerus at midline and the medial and lateral corrugators will be assessed in healthy subjects with glabellar frown lines.
- Conditions
- Glabellar Frown Lines (GL)
- Being tested
- EB-001 injection, Placebo injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EB-001 injectionDrug
Also called Botulinun Toxin Type E
Placebo injectionDrug
Also called Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Intervention: Drug: Placebo
Single Injection of placebo into five (5) 0.1 mL IM injections into glabellar area. Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: EB-001 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After single injection treatment up to 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startDec 2016
- Primary completion12 Jul 2017
- Study completion12 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glabellar Frown Lines (GL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bonti, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Earvin Liang, Study director, Bonti, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939326
- Sponsor's protocol ID
- EB001-GL201
- Status last verified
- Jan 2019
- First submitted
- 11 Oct 2016
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 30489516
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Ascending Dose Cohort Study to Evaluate Safety and Efficacy of a Single Treatment Cycle of EB-001 in Subjects With Glabellar Frown Lines
- ClinicalTrials.gov ID
- NCT02939326
- Acronym / sponsor ID
- EB001-GL201
- Conditions
- Glabellar Frown Lines (GL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bonti, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- 12 Jul 2017 (actual)
- Study completion
- 12 Jul 2017 (actual)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of EB-001 compared to placebo in subjects with glabellar frown lines (GL).
Detailed description
This study of EB-001 to measure safety and efficacy in GL. Single doses of EB- 001 administered through IM injection into procerus at midline and the medial and lateral corrugators will be assessed in healthy subjects with glabellar frown lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo injectionIntervention: Drug: Placebo Single Injection of placebo into five (5) 0.1 mL IM injections into glabellar area. |
| EB-001 Dose 1 (1X) | Active comparator | Drug: EB-001 injectionIntervention: Drug: EB-001 Single Injection of Low Dose of EB-001 into five (5) 0.1 mL IM Injections into glabellar area |
| EB-001 Dose 2 (3X) | Active comparator | Drug: EB-001 injectionIntervention: Drug: EB-001, 3X Dose 1 Single Injection of EB-001 into five (5) 0.1 mL IM Injections into glabellar area |
| EB-001 Dose 3 (9X) | Active comparator | Drug: EB-001 injectionIntervention: Drug: EB-001, 9X Dose 1 Single Injection of EB-001 into five (5) 0.1 mL IM Injections into glabellar area |
| EB-001 Dose 4 (12X) | Active comparator | Drug: EB-001 injectionIntervention: Drug: EB-001, 12X Dose 1 Single Injection of EB-001 into five (5) 0.1 mL IM Injections into glabellar area |
| EB-001 Dose 5 (16X) | Active comparator | Drug: EB-001 injectionIntervention: Drug: EB-001, 16X Dose 1 Single Injection of EB-001 into five (5) 0.1 mL IM Injections into glabellar area |
| EB-001 Dose 6 (21X) | Active comparator | Drug: EB-001 injectionIntervention: Drug: EB-001, 21X Dose 1 Single Injection of EB-001 into five (5) 0.1 mL IM Injections into glabellar area |
| EB-001 Dose 7 (28X) | Active comparator | Drug: EB-001 injectionIntervention: 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (24 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EB-001 injectionAlso: Botulinun Toxin Type E | Drug | 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 injectionAlso: Placebo | Drug | Placebo |
Primary outcome
Investigator's Assessment of GL Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS).
Time frame: After single injection treatment up to 42 days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30489516Yoelin 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Earvin Liang study director
Bonti, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EB-001 injection in people with Glabellar Frown Lines (GL), run by Bonti, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator's Assessment of GL Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS). (time frame: After single injection treatment up to 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02939326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.