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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04331080
Other study ID # 2019-SCAR-01
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date July 1, 2020
Est. completion date May 26, 2022

Study information

Verified date June 2022
Source Xequel Bio, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate effectiveness of Granexin® gel in reducing scar formation in surgical incisional wounds.


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.


Recruitment information / eligibility

Status Completed
Enrollment 184
Est. completion date May 26, 2022
Est. primary completion date May 26, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Female subjects aged 18 years and older 2. Female subjects of childbearing potential must have a negative urine or blood pregnancy test at screening and baseline. 3. 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 - Hormonal contraceptive - intra-uterine device Non-childbearing confirmed by prior documentation of at least one of the following: - postmenopausal - surgically sterilized 4. Subjects undergoing a breast surgery procedure with bilateral anchor incisions 5. Signed informed consent form Exclusion Criteria: 1. Subjects with breast implants or history of breast implants 2. Subjects undergoing breast surgery requiring breast implants 3. Subjects requiring nipple grafting using any technique 4. Subjects with a history of infection in the past 6 months in the intended area of incision 5. Subjects with breast tattoos in the intended area of the incision 6. Subjects with known skin sensitivity to Tegaderm™ 7. Subjects with a history of keloids 8. Known conditions of collagen vascular diseases 9. 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: 1. Renal insufficiency as an estimated GFR, which is < 30 mL/min/1.7m2 2. Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range 3. Hepatic insufficiency defined as total bilirubin > 2 mg/dL or serum albumin < 25 g/L 4. Hemoglobin < 9 g/dL 5. Hematocrit < 30% 6. Platelet count < 100,000 µL 10. Any history within the last 5 years or the presence of any active systemic cancer (with the exception of non-melanoma skin cancer) 11. Current treatment with systemic corticosteroids (>15 mg/day). Washout period is 30 days prior to screening 12. Current treatment with biologic immunosuppressive agents or chemotherapeutic agents. Wash out period for short term immunosuppressive agents is 14 days prior to screening 13. Previous history of radiation therapy to the chest 14. Known inability to complete required study visits during study participation 15. 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 16. Use of any investigational drug or therapy within the 28 days prior to screening 17. History of previous breast surgeries in the area where the incisions are to be made 18. Currently pregnant, pregnant during the 6 months prior to screening, lactating, or breastfeeding 19. Any other factor, which may, in the opinion of the Investigator, compromise participation and follow-up in the study 20. Any areolar abnormalities that are deemed clinically significant by the Investigator

Study Design


Intervention

Drug:
Granexin® gel 100 µM
Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.
Granexin® gel 200 µM
Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.
Vehicle gel
Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.

Locations

Country Name City State
United States Northwestern University - Feinberg School of Medicine - Division of Plastic & Reconstructive Surgery Chicago Illinois
United States Iowa Plastic Surgery Davenport Iowa
United States Universal Axon Clinical Research Doral Florida
United States Private Clinic- David Kulber Los Angeles California
United States Miami Plastic Surgery Miami Florida
United States Luxurgery New York New York
United States Pasadena Surgeons Pasadena California
United States University of Utah Salt Lake City Utah
United States Integrated Aesthetics Spring Texas
United States Ibrahim H. Amjad, MD, PA W. Miami Florida
United States Wake Forest Baptist Hospital - Plastic and Reconstructive Surgery Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Xequel Bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Month 12
Secondary 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). Month 6, Month 9 and Month 12
Secondary 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. Month 9
Secondary Proportion of subjects with incision healing complications Investigator's assessment of incision healing complications Day 1 to Month 12
Secondary Proportion of subjects with incision infection Investigator's assessment of presence or absence of infection Day 1 to Month 12
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