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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.

Tracking Information
First Submitted Date  ICMJE November 13, 2017
First Posted Date  ICMJE November 20, 2017
Results First Submitted Date  ICMJE October 17, 2018
Results First Posted Date  ICMJE December 14, 2018
Last Update Posted Date January 8, 2019
Actual Study Start Date  ICMJE February 6, 2018
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 16, 2017)
Assessment of Visual Analog Scale (VAS) Change [ Time Frame: Day 90 ]
Assessment of change in Visual Analog Scale score (values from 0 (worst) to 10 (best)) from day of surgery to Day 90
Change History Complete list of historical versions of study NCT03346902 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of EB-001 in Facial Scar Reduction
Official Title  ICMJE A Phase 2 Study to Evaluate Safety and Efficacy of EB-001 Injections in Facial Scar Reduction After Undergoing Mohs Surgery
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Mohs Surgery
Intervention  ICMJE
  • Drug: EB-001
    Injection of EB-001 into area of scarring (forehead)
  • Drug: 0.9% Sodium Chloride Injection
    Injection of Saline into area of scarring (forehead)
Study Arms  ICMJE
  • Placebo Comparator: Placebo

    Drug: : Placebo: 0.9% Sodium Chloride Injection

    Injection of Placebo into area of scarring (forehead)

    Intervention: Drug: 0.9% Sodium Chloride Injection
  • Active Comparator: EB001
    Drug: EB-001 Injection of EB-001 into area of scarring (forehead)
    Intervention: Drug: EB-001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 16, 2017)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 8, 2018
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03346902
Other Study ID Numbers  ICMJE EB001-SR201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bonti, Inc.
Study Sponsor  ICMJE Bonti, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Earvin Liang Bonti, Inc.
PRS Account Bonti, Inc.
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP