A Study Assessing KB304 for the Treatment of Wrinkles in Women (Pearl-2)

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

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 Overview

• Status: Active, not recruiting
• Conditions: Pigmentation; Décolleté Wrinkles; Wrinkles in Decolletage
• Intervention / Treatment: Biological: KB304; Drug: 0.9% Normal Saline (NS)

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Steve Yoelin Medical Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Female in good general health, as determined by the Investigator, aged ≥18 and ≤75 at the time of consent.
• Presence of moderate to severe dynamic wrinkles in the décolleté Target Area, as determined by the Investigator on the JDWS.
• A Fitzpatrick skin phototype score of I-IV.
• A negative urine pregnancy test at Screening and Day 1 (Visit 2) for subjects of child-bearing potential.
• Signed and dated informed consent and willingness to attend all study visits and complete all procedures required by the protocol.

Exclusion Criteria:

• Any transient or chronic skin condition, disorder, or infection within 20 cm of the Target Area at Day 1 (Visit 2) that, in the opinion of the Investigator, may interfere with the interpretation of study results.
• Scars, tattoos or tanned skin (defined as skin that is tanned from sun exposure, tanning beds, or an applied skin color such as a spray tan) within the Target Area at Day 1 (Visit 2).
• History of laser treatment, microneedling, chemical peels within 3 months of Day 1 (Visit 2), or botulinum toxin within 6 months of Day 1 (Visit 2) to the Target Area.
• History of surgical procedures to Target Area, including removal of benign or malignant skin cancers that, in the opinion of the Investigator, may interfere with the interpretation of study results.
• Administration of a cosmetic and/or investigational agent, in the Target Area within 6 months of Day 1 (Visit 2), that, in the opinion of the Investigator, may interfere with the interpretation of study results.
• Any condition (including a history or current evidence of substance abuse or dependence, ongoing systemic infection, infection local to the Target Area, immunosuppression, or recent history of or active malignancy in the Target Area) that, in the Investigator's opinion, would impact the subject's ability to complete all study-related procedures and/or poses an additional risk to the assessment of safety of the Investigational Product.
• Subject who is pregnant or nursing.
• Subject who is unwilling to comply with contraception requirements per-protocol.
• Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol, in the opinion of the Investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: 0.9% Normal Saline (NS); Placebo
Experimental: KB304	Biological: KB304; Genetically modified herpes simplex type 1 virus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Krystal Biotech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 8, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Krystal Biotech; wrinkles in decolletage; pigmentation in decolletage; décolleté wrinkles
• Other Study ID Numbers: KB304-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No