Study of EB-001 in Facial Scar Reduction

NCT ID: NCT03346902

Last Updated: 2019-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-06
• Study Completion Date: 2018-10-08

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.

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.

Conditions

Mohs Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Drug: : Placebo: 0.9% Sodium Chloride Injection

Injection of Placebo into area of scarring (forehead)

Group Type: PLACEBO_COMPARATOR

0.9% Sodium Chloride Injection

Intervention Type: DRUG

Injection of Saline into area of scarring (forehead)

EB001

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

Group Type: ACTIVE_COMPARATOR

EB-001

Intervention Type: DRUG

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

Interventions

EB-001

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

Intervention Type: DRUG

0.9% Sodium Chloride Injection

Injection of Saline into area of scarring (forehead)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bonti, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Earvin Liang

Role: STUDY_DIRECTOR

Bonti, Inc.

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EB001-SR201

Identifier Type: -

Identifier Source: org_study_id