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A Study Assessing KB304 for the Treatment of Wrinkles in Women

NCT06724900 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-05-13

No results posted yet for this study

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

BIOLOGICAL

KB304

Genetically modified herpes simplex type 1 virus

DRUG

0.9% Normal Saline (NS)

Placebo

Sponsors & Collaborators

  • Krystal Biotech, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-20
Primary Completion
2025-07-31
Completion
2025-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06724900 on ClinicalTrials.gov