Scar Formation
Conditions
Keywords
GBT009, incisional scar, breast reconstruction
Brief summary
The primary objective of this study is to assess whether intradermal injections of GBT009 along full thickness incisions following surgery results in an improvement in scar appearance.
Interventions
BIOLOGICALGBT009
Intradermal Injection following surgery
BIOLOGICALPlacebo
Intradermal Injection following surgery
Sponsors
Garnet BioTherapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following criteria to be considered eligible to participate in the study: * be a female between 18 and 70 years of age, inclusive * have a body mass index ≤ 32 kg/m2 and a body weight between 50 and 95 kg, inclusive * be scheduled for a mastectomy with breast reconstruction surgery using an abdominal flap technique * for women diagnosed with breast cancer, has standard of care treatment for breast cancer prior to surgery and will have standard of care treatment for breast cancer after surgery * for subjects of childbearing potential, be surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA through completion of the study and have negative results on a serum pregnancy test done before administration of study medication (women who are postmenopausal \[no menses for at least 2 years\] are also eligible to participate) * be able to understand the study procedures, agree to participate in the study program, and voluntarily provide written informed consent
Exclusion criteria
Subjects who meet any of the following criteria will be excluded from participating in the study: * have clinically significant laboratory abnormalities at screening * have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, coagulopathic disorder or other condition that would preclude participation in the study * have received treatment for a severe, uncontrolled inflammatory disease or allergic condition within three months of screening * have a life expectancy ≤ 2 years * have a history of alcoholism or drug addiction or abuse within 5 years * have evidence of a clinically significant abnormality upon evaluation of 12 lead ECG * have evidence of any past or present clinically significant medical condition, including skin disease, that would impair wound healing * have a history of keloid scar formation * have existing scarring in the abdominal area of study that would interfere with the efficacy assessments * have a history of (within the past 5 years) or an active malignancy, other than breast cancer * have a breast cancer that has been staged at Stage IIIB, IIIC or IV * have received a cytotoxic agent or have been treated with radiation within 90 days of screening and/or, in the opinion of the investigator, will likely require treatment in the 30 day period following the administration of study medication * have received anticoagulation medication within 5 days of dosing with study medication * have participated in any study involving an investigational product within 30 days before dosing with study medication * have routinely used tobacco products within 6 months preceding the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Photography- Independent Scar Assessment Panel | 0.5, 1, 2, 3, 6, 9 and 12 Months | An independent panel was planned to review scar photography to determine more preferable outcomes. Panel was not performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Scar Preference | 12 Month (End of Study) | Overall preference of the healing/appearance of each scar segment as completed by investigator and subject. |
| Patient Observer Scar Assessment Scale (POSAS) | 12 Month (End of Study) | Rating by subject and investigator (observer) to assess various factors of scar segment appearance/characteristics on a numeric scale (0-10). Individual parameters rated by the subject or observer according to a 0-10 scale where 0 equals no symptoms or difference from normal (better) and 10 equals the worst possible symptoms or difference from normal (worse). Outcomes measured at 0.5, 1, 2, 3, 6, 9 and 12 Months. Reported Data is end of study (12 months) |
| Manchester Scar Scale (MSS) | 12 Month (End of Study) | Rating by investigator to assess various factors of scar appearance/characteristics on numeric scales. MSS includes a visual analog scale (10 cm; 0 excellent appearance, 10 poor appearance) and four descriptive characteristics rated 1 to 4 according to the following descriptions. Color: Perfect (1), Slight mismatch (2), Obvious mismatch (3), Gross mismatch (4). Contour: Flush with surrounding skin (1), Slightly proud/indented (2), Hypertrophic (3), Keloid (4). Distortion: None (1), Mild (2), Moderate (3), Severe (4). Texture: Normal (1), Just palpable (2), Firm (3), Hard (4). Outcomes measured at 0.5, 1, 2, 3, 6, 9 and 12 Months. Reported Data is end of study (12 months) |
Countries
United States
Participant flow
Recruitment details
Subjects were screened and enrolled at two US centers (surgical practices) beginning in February 2010. The last subject completed participation in October 2011
Participants by arm
| Arm | Count |
|---|---|
| GBT009/Placebo All subjects acted as their own control receiving both GBT009 and Placebo | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | GBT009/Placebo |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age Continuous | 48 years STANDARD_DEVIATION 9.43 |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 5 |
| serious Total, serious adverse events | 3 / 5 |
Outcome results
Primary
Photography- Independent Scar Assessment Panel
An independent panel was planned to review scar photography to determine more preferable outcomes. Panel was not performed.
Time frame: 0.5, 1, 2, 3, 6, 9 and 12 Months
Population: All subjects had scar photography completed at study visits. However, due to the early termination of this trial, the independent panel review was not completed.
Secondary
Manchester Scar Scale (MSS)
Rating by investigator to assess various factors of scar appearance/characteristics on numeric scales. MSS includes a visual analog scale (10 cm; 0 excellent appearance, 10 poor appearance) and four descriptive characteristics rated 1 to 4 according to the following descriptions. Color: Perfect (1), Slight mismatch (2), Obvious mismatch (3), Gross mismatch (4). Contour: Flush with surrounding skin (1), Slightly proud/indented (2), Hypertrophic (3), Keloid (4). Distortion: None (1), Mild (2), Moderate (3), Severe (4). Texture: Normal (1), Just palpable (2), Firm (3), Hard (4). Outcomes measured at 0.5, 1, 2, 3, 6, 9 and 12 Months. Reported Data is end of study (12 months)
Time frame: 12 Month (End of Study)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT009 | Manchester Scar Scale (MSS) | Color (1-4) | 2.6 units on a scale | Standard Deviation 0.55 |
| GBT009 | Manchester Scar Scale (MSS) | Distortion (1-4) | 1.8 units on a scale | Standard Deviation 0.45 |
| GBT009 | Manchester Scar Scale (MSS) | Contour (1-4) | 1.6 units on a scale | Standard Deviation 0.55 |
| GBT009 | Manchester Scar Scale (MSS) | Texture (1-4) | 4.8 units on a scale | Standard Deviation 1.79 |
| GBT009 | Manchester Scar Scale (MSS) | Visual Analog Scale (0-10) | 4.26 units on a scale | Standard Deviation 2.62 |
| Placebo | Manchester Scar Scale (MSS) | Texture (1-4) | 4.6 units on a scale | Standard Deviation 1.82 |
| Placebo | Manchester Scar Scale (MSS) | Visual Analog Scale (0-10) | 4.26 units on a scale | Standard Deviation 2.32 |
| Placebo | Manchester Scar Scale (MSS) | Color (1-4) | 2.4 units on a scale | Standard Deviation 0.55 |
| Placebo | Manchester Scar Scale (MSS) | Contour (1-4) | 1.4 units on a scale | Standard Deviation 0.55 |
| Placebo | Manchester Scar Scale (MSS) | Distortion (1-4) | 1.8 units on a scale | Standard Deviation 0.45 |
Secondary
Overall Scar Preference
Overall preference of the healing/appearance of each scar segment as completed by investigator and subject.
Time frame: 12 Month (End of Study)
Population: All Subjects included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBT009 | Overall Scar Preference | Investigator Evaluation | 4 participants |
| GBT009 | Overall Scar Preference | Subject Evaluation | 2 participants |
| Placebo | Overall Scar Preference | Investigator Evaluation | 0 participants |
| Placebo | Overall Scar Preference | Subject Evaluation | 2 participants |
| No Difference | Overall Scar Preference | Investigator Evaluation | 1 participants |
| No Difference | Overall Scar Preference | Subject Evaluation | 1 participants |
Secondary
Patient Observer Scar Assessment Scale (POSAS)
Rating by subject and investigator (observer) to assess various factors of scar segment appearance/characteristics on a numeric scale (0-10). Individual parameters rated by the subject or observer according to a 0-10 scale where 0 equals no symptoms or difference from normal (better) and 10 equals the worst possible symptoms or difference from normal (worse). Outcomes measured at 0.5, 1, 2, 3, 6, 9 and 12 Months. Reported Data is end of study (12 months)
Time frame: 12 Month (End of Study)
Population: All subjects were included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT009 | Patient Observer Scar Assessment Scale (POSAS) | Thickness (Subject) | 3.8 units on a scale | Standard Deviation 3.56 |
| GBT009 | Patient Observer Scar Assessment Scale (POSAS) | Vascularization (Observer) | 4.8 units on a scale | Standard Deviation 1.79 |
| GBT009 | Patient Observer Scar Assessment Scale (POSAS) | Pigmentation (Observer) | 4.4 units on a scale | Standard Deviation 1.14 |
| GBT009 | Patient Observer Scar Assessment Scale (POSAS) | Thickness (Observer) | 3.4 units on a scale | Standard Deviation 2.07 |
| GBT009 | Patient Observer Scar Assessment Scale (POSAS) | Relief (Observer) | 3.6 units on a scale | Standard Deviation 1.82 |
| GBT009 | Patient Observer Scar Assessment Scale (POSAS) | Pliability (Observer) | 3 units on a scale | Standard Deviation 1.41 |
| GBT009 | Patient Observer Scar Assessment Scale (POSAS) | Pain (Subject) | 1 units on a scale | Standard Deviation 0 |
| GBT009 | Patient Observer Scar Assessment Scale (POSAS) | Itching (Subject) | 1 units on a scale | Standard Deviation 0 |
| GBT009 | Patient Observer Scar Assessment Scale (POSAS) | Color (Subject) | 5.4 units on a scale | Standard Deviation 2.88 |
| GBT009 | Patient Observer Scar Assessment Scale (POSAS) | Stiffness (Subject) | 3.4 units on a scale | Standard Deviation 3.78 |
| GBT009 | Patient Observer Scar Assessment Scale (POSAS) | Irregularity (Subject) | 4 units on a scale | Standard Deviation 2.74 |
| Placebo | Patient Observer Scar Assessment Scale (POSAS) | Irregularity (Subject) | 4 units on a scale | Standard Deviation 2.65 |
| Placebo | Patient Observer Scar Assessment Scale (POSAS) | Pain (Subject) | 1 units on a scale | Standard Deviation 0 |
| Placebo | Patient Observer Scar Assessment Scale (POSAS) | Vascularization (Observer) | 4.6 units on a scale | Standard Deviation 1.82 |
| Placebo | Patient Observer Scar Assessment Scale (POSAS) | Stiffness (Subject) | 3 units on a scale | Standard Deviation 3.94 |
| Placebo | Patient Observer Scar Assessment Scale (POSAS) | Pigmentation (Observer) | 4.4 units on a scale | Standard Deviation 1.52 |
| Placebo | Patient Observer Scar Assessment Scale (POSAS) | Itching (Subject) | 1 units on a scale | Standard Deviation 0 |
| Placebo | Patient Observer Scar Assessment Scale (POSAS) | Thickness (Observer) | 2.6 units on a scale | Standard Deviation 1.52 |
| Placebo | Patient Observer Scar Assessment Scale (POSAS) | Thickness (Subject) | 3.8 units on a scale | Standard Deviation 3.7 |
| Placebo | Patient Observer Scar Assessment Scale (POSAS) | Relief (Observer) | 3.4 units on a scale | Standard Deviation 1.52 |
| Placebo | Patient Observer Scar Assessment Scale (POSAS) | Color (Subject) | 4.6 units on a scale | Standard Deviation 3.2 |
| Placebo | Patient Observer Scar Assessment Scale (POSAS) | Pliability (Observer) | 2.4 units on a scale | Standard Deviation 1.52 |