MammoplastyPhase 2/3NCT04331080
A Study of Granexin® Gel for the Reduction of Scar Formation in Surgical Wounds Following Bilateral Anchor Incision Breast Surgery
A Phase 2/3 study testing Granexin® gel 100 μM and Granexin® gel 200 μM in people with Mammoplasty and Scarring, run by Xequel Bio, Inc. at 11 sites in United States.
Trial summary
The purpose of this study is to evaluate effectiveness of Granexin® gel in reducing scar formation in surgical incisional wounds. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mammoplasty, Scarring, Scar
- What is being tested?
- Granexin® gel 100 μM and Granexin® gel 200 μM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 11 sitesUnited States
- Study dates
- 1 Jul 2020to 26 May 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female subjects aged 18 years and older
- Female subjects of childbearing potential must have a negative urine or blood pregnancy test at screening and baseline.
- Female subjects of childbearing potential must agree to use ONE of the following birth control methods throughout the study:
- abstinence
- condom with spermicide
- diaphragm with spermicide
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- Hormonal contraceptive
- intra-uterine device
- Non-childbearing confirmed by prior documentation of at least one of the following:
- postmenopausal
- surgically sterilized
- Subjects undergoing a breast surgery procedure with bilateral anchor incisions
- Signed informed consent form
Who cannot join
- Subjects with breast implants or history of breast implants
- Subjects undergoing breast surgery requiring breast implants
- Subjects requiring nipple grafting using any technique
- Subjects with a history of infection in the past 6 months in the intended area of incision
- Subjects with breast tattoos in the intended area of the incision
- Subjects with known skin sensitivity to Tegaderm™
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- Subjects with a history of keloids
- Known conditions of collagen vascular diseases
- Subjects with clinically significant medical conditions as determined by the Investigator, which would impair wound healing including renal, hepatic, hematologic, neurologic or autoimmune disease. Examples include but are not limited to:
- Renal insufficiency as an estimated GFR, which is < 30 mL/min/1.7m2
- Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range
- Hepatic insufficiency defined as total bilirubin > 2 mg/dL or serum albumin < 25 g/L
- Hemoglobin < 9 g/dL
- Hematocrit < 30%
- Platelet count < 100,000 μL
- Any history within the last 5 years or the presence of any active systemic cancer (with the exception of non-melanoma skin cancer)
- Current treatment with systemic corticosteroids (>15 mg/day). Washout period is 30 days prior to screening
- Current treatment with biologic immunosuppressive agents or chemotherapeutic agents. Wash out period for short term immunosuppressive agents is 14 days prior to screening
- Previous history of radiation therapy to the chest
- Known inability to complete required study visits during study participation
- A psychiatric condition (e.g., suicidal ideation), chronic alcohol consumption, or drug abuse problem determined from the subject's medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance
- Use of any investigational drug or therapy within the 28 days prior to screening
- History of previous breast surgeries in the area where the incisions are to be made
- Currently pregnant, pregnant during the 6 months prior to screening, lactating, or breastfeeding
- Any other factor, which may, in the opinion of the Investigator, compromise participation and follow-up in the study
- Any areolar abnormalities that are deemed clinically significant by the Investigator
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Northwestern University - Feinberg School of Medicine - Division of Plastic & Reconstructive Surgery
Chicago, Illinois, 60611
Iowa Plastic Surgery
Davenport, Iowa, 52807
Universal Axon Clinical Research
Doral, Florida, 33166
Private Clinic- David Kulber
Los Angeles, California, 90048
Miami Plastic Surgery
Miami, Florida, 33176
Luxurgery
New York, New York, 10021
Pasadena Surgeons
Pasadena, California, 91105
University of Utah
Salt Lake City, Utah, 84132
Integrated Aesthetics
Spring, Texas, 77388
Ibrahim H. Amjad, MD, PA
West Miami, Florida, 33144
Wake Forest Baptist Hospital - Plastic and Reconstructive Surgery
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase 2b/3 Randomized, Prospective, Double Blind, Within-Subject Vehicle Controlled, Multi-Center Study to Determine the Efficacy and Safety of Granexin® Gel in Reducing Scar Formation in Surgical Wounds Following Bilateral Anchor Incision Breast Surgery
The purpose of this study is to evaluate effectiveness of Granexin® gel in reducing scar formation in surgical incisional wounds.
Read the detailed description
Participants that meet screening criteria will be eligible for randomization providing all other criteria are met. Participants enrolled will receive study drug for 3 days. The participants will have an additional follow-up period to assess scarring of both Granexin® gel and Vehicle gel incisions through end of study at Month 12.
- Conditions
- Mammoplasty, Scarring, Scar, Breast Reconstruction
- Being tested
- Granexin® gel 100 μM, Granexin® gel 200 μM, Vehicle gel
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granexin® gel 100 μMDrug
Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.
Granexin® gel 200 μMDrug
Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.
Vehicle gelDrug
Also called placebo
Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.
| Study group | Role | What they receive |
|---|---|---|
| Granexin® gel 100 μM | Experimental | Within-subject comparison of Granexin® Gel versus vehicle gel (placebo).
Granexin® gel 100 μM will be applied four times over three days: twice during surgery, 24 hours after surgery and 48 hours after surgery. Granexin® will be applied on the right or left breast according to a randomization list. Receives: Drug: Granexin® gel 100 μM; Drug: Vehicle gel |
| Granexin® gel 200 μM | Experimental | Within-subject comparison of Granexin® Gel versus vehicle gel (placebo).
Granexin® gel 200 μM will be applied four times over three days: twice during surgery, 24 hours after surgery and 48 hours after surgery. Granexin® will be applied on the right or left breast according to a randomization list. Receives: Drug: Granexin® gel 200 μM; Drug: Vehicle gel |
| Vehicle Gel | Placebo comparator | Within-subject comparison of Granexin® Gel versus vehicle gel (placebo).
Vehicle gel will be applied four times over three days: twice during surgery, 24 hours after surgery and 48 hours after surgery. Granexin® will be applied on the right or left breast according to a randomization list. Receives: Drug: Granexin® gel 100 μM; Drug: Granexin® gel 200 μM; Drug: Vehicle gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scar severity at Month 12
Assessed using the Patient and Observer Scar Assessment Scale (POSAS). The POSAS has a rage from 6 to 60 with higher scores indicating worse outcomes. One scale will be used for each segment of the scar. The score from each segment will be combined into one score.
Measured: Month 12
Secondary outcomes (4)
Change in scar severity at Month 6, Month 9 and Month 12
Assessed using the Scar Cosmesis Assessment and Rating (SCAR) Scale. The SCAR scale has a range of 0 (best possible scar) to 15 (worst possible scar).
Measured: Month 6, Month 9 and Month 12
Change in scar severity at Month 9
Assessed using the Patient and Observer Scar Assessment Scale (POSAS). The POSAS has a range from 6 to 60 with higher scores indicating worse outcomes. One scale will be used for each segment of the scar. The score from each segment will be combined into one score.
Measured: Month 9
Proportion of subjects with incision healing complications
Investigator's assessment of incision healing complications
Measured: Day 1 to Month 12
Proportion of subjects with incision infection
Investigator's assessment of presence or absence of infection
Measured: Day 1 to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Jul 2020
- Primary completion26 May 2022
- Study completion26 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MammoplastyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xequel Bio, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331080
- Sponsor's protocol ID
- 2019-SCAR-01
- Status last verified
- Jun 2022
- First submitted
- 31 Mar 2020
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b/3 Randomized, Prospective, Double Blind, Within-Subject Vehicle Controlled, Multi-Center Study to Determine the Efficacy and Safety of Granexin® Gel in Reducing Scar Formation in Surgical Wounds Following Bilateral Anchor Incision Breast Surgery
- ClinicalTrials.gov ID
- NCT04331080
- Acronym / sponsor ID
- 2019-SCAR-01
- Conditions
- Mammoplasty, Scarring, Scar, Breast Reconstruction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Xequel Bio, Inc.University, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 26 May 2022 (actual)
- Study completion
- 26 May 2022 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate effectiveness of Granexin® gel in reducing scar formation in surgical incisional wounds.
Detailed description
Participants that meet screening criteria will be eligible for randomization providing all other criteria are met. Participants enrolled will receive study drug for 3 days. The participants will have an additional follow-up period to assess scarring of both Granexin® gel and Vehicle gel incisions through end of study at Month 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Granexin® gel 100 μM | Experimental | Drug: Granexin® gel 100 μM, Drug: Vehicle gelWithin-subject comparison of Granexin® Gel versus vehicle gel (placebo). Granexin® gel 100 μM will be applied four times over three days: twice during surgery, 24 hours after surgery and 48 hours after surgery. Granexin® will be applied on the right or left breast according to a randomization list. |
| Granexin® gel 200 μM | Experimental | Drug: Granexin® gel 200 μM, Drug: Vehicle gelWithin-subject comparison of Granexin® Gel versus vehicle gel (placebo). Granexin® gel 200 μM will be applied four times over three days: twice during surgery, 24 hours after surgery and 48 hours after surgery. Granexin® will be applied on the right or left breast according to a randomization list. |
| Vehicle Gel | Placebo comparator | Drug: Granexin® gel 100 μM, Drug: Granexin® gel 200 μM, Drug: Vehicle gelWithin-subject comparison of Granexin® Gel versus vehicle gel (placebo). Vehicle gel will be applied four times over three days: twice during surgery, 24 hours after surgery and 48 hours after surgery. Granexin® will be applied on the right or left breast according to a randomization list. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Female subjects aged 18 years and older
- Female subjects of childbearing potential must have a negative urine or blood pregnancy test at screening and baseline.
- Female subjects of childbearing potential must agree to use ONE of the following birth control methods throughout the study:
- Subjects undergoing a breast surgery procedure with bilateral anchor incisions
- Signed informed consent form
Key exclusion criteria (26 listed)
- Subjects with breast implants or history of breast implants
- Subjects undergoing breast surgery requiring breast implants
- Subjects requiring nipple grafting using any technique
- Subjects with a history of infection in the past 6 months in the intended area of incision
- Subjects with breast tattoos in the intended area of the incision
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 |
|---|---|---|
| Granexin® gel 100 μMAdministered during the surgery, 24 hours post-surgery, and 48 hours post-surgery. | Drug | Granexin® gel 100 μM, Vehicle Gel |
| Granexin® gel 200 μMAdministered during the surgery, 24 hours post-surgery, and 48 hours post-surgery. | Drug | Granexin® gel 200 μM, Vehicle Gel |
| Vehicle gelAlso: placeboAdministered during the surgery, 24 hours post-surgery, and 48 hours post-surgery. | Drug | Granexin® gel 100 μM, Granexin® gel 200 μM, Vehicle Gel |
Primary outcome
Change in scar severity at Month 12
Time frame: Month 12
Assessed using the Patient and Observer Scar Assessment Scale (POSAS). The POSAS has a rage from 6 to 60 with higher scores indicating worse outcomes. One scale will be used for each segment of the scar. The score from each segment will be combined into one score.
4 secondary outcomes
Change in scar severity at Month 6, Month 9 and Month 12
Time frame: Month 6, Month 9 and Month 12
Change in scar severity at Month 9
Time frame: Month 9
Proportion of subjects with incision healing complications
Time frame: Day 1 to Month 12
Proportion of subjects with incision infection
Time frame: Day 1 to Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Granexin® gel 100 μM and Granexin® gel 200 μM in people with Mammoplasty and Scarring, run by Xequel Bio, Inc. at 11 sites 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 13 inclusion and 26 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 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in scar severity at Month 12 (time frame: Month 12). 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 6 Jun 2022.