The aim of this study is to investigate the safety and efficacy of KB304, an investigational gene therapy to correct moderate to severe wrinkles in the décolleté region (V-shaped chest area). KB304 is an investigational gene therapy that delivers functional, full-length human collagen (COL3) and elastin (tropoelastin) to the skin through small injections using the Sponsor's genetically engineered Herpes Simplex Virus (HSV-1) vector. The study is a randomized double-blind study and participants will receive either KB304 (active group) or placebo (inactive group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
19
Genetically modified herpes simplex type 1 virus
Placebo
Steve Yoelin Medical Associates
Newport Beach, California, United States
Safety and tolerability of KB304 versus placebo administered by intradermal injection
Treatment related adverse events as assessed by CTCAE
Time frame: Up to 4 months
To evaluate the effect of KB304 versus placebo on dynamic wrinkles of the décolleté area.
Change from baseline as compared to placebo in the Investigator's live assessment (using a 6-Point Global Aesthetic Improvement Scale (GAIS)) and the participants' self-assessment where +2 is much improved and -2 is not applicable.
Time frame: Up to 4 months
To evaluate the effect of KB304 versus placebo on dynamic wrinkles of the décolleté area.
Change from baseline as compared to placebo in the Investigator's live assessment (using a 5-Point Jeune Décolleté Wrinkle (JDWS) Photographic Scale) where 0 is none and 4 is extremely severe.
Time frame: Up to 4 months
To evaluate the effect of KB304 versus placebo on dynamic wrinkles of the décolleté area.
Change from baseline as compared to placebo in subject satisfaction using a 6-Point Scale where +2 is very satisfied and -2 is not applicable.
Time frame: Up to 4 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.