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A Study Assessing KB304 for the Treatment of Wrinkles in Women

Study acronym: Pearl-2
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 13, 2025 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 21 to confirmed 19
    • Primary completion date: May 2025 to Jul 2025
    • Site details revised
    v3
  2. Secondary endpoints: details revised at 3 of 3 entriesv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06724900
Lead Sponsor Krystal Biotech, Inc.
Conditions
(from sponsor)		 Wrinkles in Decolletage, Pigmentation, Décolleté Wrinkles
Enrollment 19 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov