Status:
COMPLETED
Study of EB-001 in Facial Scar Reduction
Lead Sponsor:
Bonti, Inc.
Conditions:
Mohs Surgery
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- Basal Cell Carcinoma
- Squamous Cell Carcinoma (non-metastatic)
- Other suitable lesions according to the investigator opinion
- 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
- a highly effective method of contraception with failures rates less than 1% per year such as implant, intrauterine device (IUD), or sterilization from the day of dosing for 3 months (subjects who underwent sterilization must have initiated the procedure at least 3 months prior to the day of dosing) or
- dual methods of contraception with overall failures rates less than 1% per year such as injectable, pill, patch, ring, and diaphragm from the day of dosing for 3 months (subjects using oral contraception must have initiated treatment at least 2 months prior to the day of dosing)
- 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
- 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:
- including but not limited to cigarettes, cigars, and chewing or dipping tobacco) who stopped use or consumption (i.e., smoking, chewing, or pinching) of these nicotine-containing products less than 1 year before study drug administration, or
- topical or oral nicotine preparations for smoking cessation within the past 90 days before study drug administration
- 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
Key Trial Info
Start Date :
February 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03346902
Start Date
February 6 2018
End Date
October 8 2018
Last Update
January 8 2019
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611