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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KB304 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KB304 | Biological | Genetically modified herpes simplex type 1 virus |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of KB304 versus placebo administered by intradermal injection | Treatment related adverse events as assessed by CTCAE | Up to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steve Yoelin Medical Associates | Newport Beach | California | 92663 | United States |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| 0.9% Normal Saline (NS) |
| Drug |
Placebo |
|
| 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. |
| 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. | Up to 4 months |