A Study Assessing KB304 for the Treatment of Wrinkles in Women

NCT06724900 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: KB304-01
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Krystal Biotech; wrinkles in decolletage; pigmentation in decolletage; décolleté wrinkles

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of KB304 versus placebo administered by intradermal injection

  Treatment related adverse events as assessed by CTCAE

  Up to 4 months

Secondary Outcomes (3)

• To evaluate the effect of KB304 versus placebo on dynamic wrinkles of the décolleté area.

  Up to 4 months

• To evaluate the effect of KB304 versus placebo on dynamic wrinkles of the décolleté area.

  Up to 4 months

• To evaluate the effect of KB304 versus placebo on dynamic wrinkles of the décolleté area.

  Up to 4 months

Study Arms (2)

KB304

EXPERIMENTAL

Biological: KB304

Placebo

PLACEBO COMPARATOR

Drug: 0.9% Normal Saline (NS)

Interventions

KB304 BIOLOGICAL

Genetically modified herpes simplex type 1 virus

KB304

0.9% Normal Saline (NS) DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Krystal Biotech, Inc.: lead

Study Sites (1)

Steve Yoelin Medical Associates

Newport Beach, California, 92663, United States

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: November 20, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 13, 2025

Record last verified: 2024-12

Locations

US (1)