Study of EB-001 in Facial Scar Reduction

A Phase 2 Study to Evaluate Safety and Efficacy of EB-001 Injections in Facial Scar Reduction After Undergoing Mohs Surgery

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.

Study Overview

• Status: Completed
• Conditions: Mohs Surgery
• Intervention / Treatment: Drug: 0.9% Sodium Chloride Injection; Drug: EB-001

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 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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Between 18 and 75 years of age, inclusive
2. Subject in good health, or with stable treated medical condition, as determined by the investigator.

3. Scheduled to undergo Mohs surgery to remove a single skin lesion in the forehead. This could be

   1. Basal Cell Carcinoma
   2. Squamous Cell Carcinoma (non-metastatic)
   3. Other suitable lesions according to the investigator opinion
4. Lesion closure size at least 2 cm in length
5. Women of non-childbearing potential must be postmenopausal (at least 12 consecutive months of amenorrhea)
6. Women of childbearing potential must not be pregnant, lactating, or planning to become pregnant during the study

7. Women of childbearing potential agreeing to use either

   1. 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
   2. 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)
8. Willing and able to complete and comply with procedures, protocol requirements and instructions, which includes completion of all required visits
9. Willing and able to sign and date IRB-approved informed consent
10. Able to speak, read, and understand the language of the informed consent form (ICF) and study questionnaires

Exclusion Criteria:

1. Pregnant or breast feeding, or planning a pregnancy
2. Body weight less than 50 kg (110 pounds)
3. Reported use of any botulinum toxin of any serotype within last 6 months before study drug administration
4. Anticipated use of any botulinum toxin of any serotype during the study
5. Known hypersensitivity to any botulinum toxin serotype
6. Known allergy or sensitivity to any of the components of the study treatments, or any materials used in the study procedures
7. Aminoglycoside intake within 48 hours prior to or during surgery
8. Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral Sclerosis)
9. Any uncontrolled medical condition that in opinion of investigator, puts subject at undue safety risk
10. Any clinically significant psychiatric condition that, in opinion of investigator, may interfere with study assessments or protocol compliance
11. Any cosmetic procedure, laser resurfacing treatment, or retinoid therapy in the forehead area in the past 30 days before study drug administration
12. Any eyebrow or eyelid ptosis at baseline as determined by the Investigator
13. History of hypertrophic scars or keloid formation or other wound abnormalities as assessed by the investigator
14. History of alcohol or drug abuse in the last 3 years, based on investigator judgement

15. User or former user of nicotine-containing products, as follows:

    1. 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
    2. topical or oral nicotine preparations for smoking cessation within the past 90 days before study drug administration
16. Anticipated need for surgery or overnight hospitalization during the study
17. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Drug: : Placebo: 0.9% Sodium Chloride Injection Injection of Placebo into area of scarring (forehead)	Drug: 0.9% Sodium Chloride Injection; Injection of Saline into area of scarring (forehead)
Active Comparator: EB001; Drug: EB-001 Injection of EB-001 into area of scarring (forehead)	Drug: EB-001; Injection of EB-001 into area of scarring (forehead)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Bonti, Inc.
• Investigators: Study Director: Earvin Liang, Bonti, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2018
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): October 8, 2018

Study Registration Dates

• First Submitted: November 13, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: December 14, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: EB001-SR201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No