Mohs SurgeryPhase 2NCT03346902
Study of EB-001 in Facial Scar Reduction
A Phase 2 study testing EB-001 and 0.9% Sodium Chloride Injection in people with Mohs Surgery, run by Bonti, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mohs Surgery
- What is being tested?
- EB-001 and 0.9% Sodium Chloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2018to 8 Oct 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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:
- 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
- topical or oral nicotine preparations for smoking cessation within the past 90 days before study drug administration
- Anticipated need for surgery or overnight hospitalization during the study
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- EB-001, 0.9% Sodium Chloride Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EB-001Drug
Injection of EB-001 into area of scarring (forehead)
0.9% Sodium Chloride InjectionDrug
Injection of Saline into area of scarring (forehead)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Drug: : Placebo: 0.9% Sodium Chloride Injection
Injection of Placebo into area of scarring (forehead) Receives: Drug: 0.9% Sodium Chloride Injection |
| EB001 | Active comparator | Drug: EB-001 Injection of EB-001 into area of scarring (forehead) Receives: Drug: EB-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start6 Feb 2018
- Primary completion31 Jul 2018
- Study completion8 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mohs SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bonti, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Earvin Liang, Study director, Bonti, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346902
- Sponsor's protocol ID
- EB001-SR201
- Status last verified
- Dec 2018
- First submitted
- 13 Nov 2017
- Last updated
- 8 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate Safety and Efficacy of EB-001 Injections in Facial Scar Reduction After Undergoing Mohs Surgery
- ClinicalTrials.gov ID
- NCT03346902
- Acronym / sponsor ID
- EB001-SR201
- Conditions
- Mohs Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Bonti, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 8 Oct 2018 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Posted 14 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: 0.9% Sodium Chloride InjectionDrug: : Placebo: 0.9% Sodium Chloride Injection Injection of Placebo into area of scarring (forehead) |
| EB001 | Active comparator | Drug: EB-001Drug: EB-001 Injection of EB-001 into area of scarring (forehead) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
- Lesion closure size at least 2 cm in length
- Women of non-childbearing potential must be postmenopausal (at least 12 consecutive months of amenorrhea)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EB-001Injection of EB-001 into area of scarring (forehead) | Drug | EB001 |
| 0.9% Sodium Chloride InjectionInjection of Saline into area of scarring (forehead) | Drug | Placebo |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Mohs Surgery
Not yet recruitingPhase 1
Amnion Membrane Powder Mohs Study
Wound Heal
Not yet recruiting
Cyanoacrylate Skin Adhesive After Mohs Surgery or Wide Local Excision
Surgical Site Infection, Skin Cancer
Not yet recruitingPhase 2
The Effects of Timolol On Healing and Cosmesis of Mohs Scalp Wounds: An Open Label Trial
Surgical Wounds, Mohs Surgery
Not yet recruitingPhase 4
Skin Subs vs Secondary Intention
Skin Substitutes, Secondary Intention Healing
Not yet recruiting
Intraoperative CO₂ (Carbon Dioxide)
Wound Edges
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Earvin Liang study director
Bonti, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EB-001 and 0.9% Sodium Chloride Injection in people with Mohs Surgery, run by Bonti, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Visual Analog Scale (VAS) Change (Values From 0 (Worst) to 10 (Best)) (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.