NCT06724900

A Study Assessing KB304 for the Treatment of Wrinkles in Women

A Phase 1/2 Study of KB304, a Replication-Defective, Non-Integrating Vector Expressing Human Type III Collagen (COL3) and Tropoelastin for the Treatment of Wrinkles

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Krystal Biotech, Inc. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Wrinkles in Decolletage
• Pigmentation
• Décolleté Wrinkles

Interventions

Type	Name	Description
BIOLOGICAL	KB304	Genetically modified herpes simplex type 1 virus
DRUG	0.9% Normal Saline (NS)	Placebo

Timeline

• Start date: 2024-11-20
• Primary completion: 2025-07-01
• Completion: 2025-08-01
• First posted: 2024-12-09
• Last updated: 2025-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study