Study of EB-001 in Facial Scar Reduction

NCT03346902 | Completed Phase 2 Results FDA Drug

• 1 other identifier: EB001-SR201
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 single treatment of EB-001 when injected into the muscles underlying the incision area.

Conditions

Mohs Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: : Placebo: 0.9% Sodium Chloride Injection Injection of Placebo into area of scarring (forehead)

Drug: 0.9% Sodium Chloride Injection

EB001

ACTIVE COMPARATOR

Drug: EB-001 Injection of EB-001 into area of scarring (forehead)

Drug: EB-001

Interventions

EB-001 DRUG

Injection of EB-001 into area of scarring (forehead)

EB001

0.9% Sodium Chloride Injection DRUG

Injection of Saline into area of scarring (forehead)

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Bonti, Inc.: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Wajdie Ahmad
• Organization: Bonti

wajdie@bonti.com

9493796569

Study Officials

• Earvin Liang

  Bonti, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 20, 2017
• Study Start: February 6, 2018
• Primary Completion: July 31, 2018
• Study Completion: October 8, 2018
• Last Updated: January 8, 2019
• Results First Posted: December 14, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)