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Study of EB-001 in Facial Scar Reduction

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ClinicalTrials.gov Identifier: NCT03346902
Recruitment Status : Completed
First Posted : November 20, 2017
Results First Posted : December 14, 2018
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Bonti, Inc.

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.

Condition or disease Intervention/treatment Phase
Mohs Surgery Drug: EB-001 Drug: 0.9% Sodium Chloride Injection Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Evaluate Safety and Efficacy of EB-001 Injections in Facial Scar Reduction After Undergoing Mohs Surgery
Actual Study Start Date : February 6, 2018
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : October 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

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)




Primary Outcome Measures :
  1. Assessment of Visual Analog Scale (VAS) Change (Values From 0 (Worst) to 10 (Best)) [ Time Frame: Day 30 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03346902


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Bonti, Inc.
Investigators
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Study Director: Earvin Liang Bonti, Inc.
  Study Documents (Full-Text)

Documents provided by Bonti, Inc.:

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Responsible Party: Bonti, Inc.
ClinicalTrials.gov Identifier: NCT03346902     History of Changes
Other Study ID Numbers: EB001-SR201
First Posted: November 20, 2017    Key Record Dates
Results First Posted: December 14, 2018
Last Update Posted: January 8, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No