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Active, Not Recruiting

NCT Number: NCT06724900

A Study Assessing KB304 for the Treatment of Wrinkles in Women

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Steve Yoelin Medical Associates

Newport Beach, California, 92663, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KB304

Biological

Genetically modified herpes simplex type 1 virus

0.9% Normal Saline (NS)

Drug

Placebo

Primary outcomes

  1. Safety and tolerability of KB304 versus placebo administered by intradermal injection

    Time frame: Up to 4 months

    Treatment related adverse events as assessed by CTCAE

Secondary outcomes

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

    Time frame: Up to 4 months

    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.

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

    Time frame: Up to 4 months

    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.

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

    Time frame: Up to 4 months

    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.

Sponsors and collaborators

Lead sponsor

Krystal Biotech, Inc.

Industry

Registry information

Official study title

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

Acronym: Pearl-2

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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