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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5
Garnet BioTherapeutics Investigational Site
Chicago, Illinois, United States
Garnet BioTherapeutics Investigational Site
Rochester, New York, United States
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
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)
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)
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)
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