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This study will evaluate the safety and efficacy of EB-001 in improving wound healing and reducing scar formation in patients undergoing Mohs surgery for skin lesions in the forehead area following a single treatment of EB-001 when injected into the muscles underlying the incision area.
This study will evaluate the safety and efficacy of EB-001 in improving wound healing and reducing scar formation in patients undergoing Mohs surgery for skin lesions in the forehead area following a single treatment of EB-001 when injected into the muscles underlying the incision area.
The safety objective is to determine the safety and tolerability of single treatment of EB-001 when injected into facial muscles underlying a surgical wound during Mohs surgery.
The efficacy objective is to evaluate the efficacy of a single treatment of EB-001 when injected into the facial muscles (frontalis) underlying the surgical wound in improving wound healing, and reducing scar formation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Drug: : Placebo: 0.9% Sodium Chloride Injection Injection of Placebo into area of scarring (forehead) |
|
| EB001 | Active Comparator | Drug: EB-001 Injection of EB-001 into area of scarring (forehead) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EB-001 | Drug | Injection of EB-001 into area of scarring (forehead) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Visual Analog Scale (VAS) Change (Values From 0 (Worst) to 10 (Best)) | Assessment of change in Visual Analog Scale score (values from 0 (worst) to 10 (best)) from day of surgery to Day 30. Percentage of subjects reporting an improvement in Visual Analog Scale score. | Day 30 |
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Inclusion Criteria:
Between 18 and 75 years of age, inclusive
Subject in good health, or with stable treated medical condition, as determined by the investigator.
Scheduled to undergo Mohs surgery to remove a single skin lesion in the forehead. This could be
Lesion closure size at least 2 cm in length
Women of non-childbearing potential must be postmenopausal (at least 12 consecutive months of amenorrhea)
Women of childbearing potential must not be pregnant, lactating, or planning to become pregnant during the study
Women of childbearing potential agreeing to use either
Willing and able to complete and comply with procedures, protocol requirements and instructions, which includes completion of all required visits
Willing and able to sign and date IRB-approved informed consent
Able to speak, read, and understand the language of the informed consent form (ICF) and study questionnaires
Exclusion Criteria:
Pregnant or breast feeding, or planning a pregnancy
Body weight less than 50 kg (110 pounds)
Reported use of any botulinum toxin of any serotype within last 6 months before study drug administration
Anticipated use of any botulinum toxin of any serotype during the study
Known 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
Aminoglycoside intake within 48 hours prior to or during surgery
Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral Sclerosis)
Any uncontrolled medical condition that in opinion of investigator, puts subject at undue safety risk
Any clinically significant psychiatric condition that, in opinion of investigator, may interfere with study assessments or protocol compliance
Any cosmetic procedure, laser resurfacing treatment, or retinoid therapy in the forehead area in the past 30 days before study drug administration
Any eyebrow or eyelid ptosis at baseline as determined by the Investigator
History of hypertrophic scars or keloid formation or other wound abnormalities as assessed by the investigator
History of alcohol or drug abuse in the last 3 years, based on investigator judgement
User or former user of nicotine-containing products, as follows:
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
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| Name | Affiliation | Role |
|---|---|---|
| Earvin Liang | Bonti, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 0.9% Sodium Chloride Injection: Single Injection of Saline into area of scarring (forehead) |
| FG001 | EB001 | EB-001: Single Injection (0.5mL total) of EB-001 into area of scarring (forehead). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 0.9% Sodium Chloride Injection: Single Injection of Saline into area of scarring (forehead) |
| BG001 | EB001 | EB-001: Single Injection (0.5mL total) of EB-001 into area of scarring (forehead) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assessment of Visual Analog Scale (VAS) Change (Values From 0 (Worst) to 10 (Best)) | Assessment of change in Visual Analog Scale score (values from 0 (worst) to 10 (best)) from day of surgery to Day 30. Percentage of subjects reporting an improvement in Visual Analog Scale score. | mITT | Posted | Number | Percentage reporting improvement | Day 30 |
|
90 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 0.9% Sodium Chloride Injection: Single Injection of Saline into area of scarring (forehead) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asymmetry in facial features as a result of the temporal nerve being affected during the Mohs Surger | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wajdie Ahmad | Bonti | 9493796569 | 9493796569 | wajdie@bonti.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2018 | Oct 12, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 0.9% Sodium Chloride Injection |
| Drug |
Injection of Saline into area of scarring (forehead) |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | EB001 | EB-001: Single Injection (0.5mL total) of EB-001 into area of scarring (forehead) | 0 | 8 | 0 | 8 | 1 | 8 |
|
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| D017670 |
| Sodium Compounds |