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A Study Assessing KB304 for the Treatment of Wrinkles in Women | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

A Study Assessing KB304 for the Treatment of Wrinkles in Women

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

NCT06724900•Krystal Biotech, Inc.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

Yes

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

Locations (1)

Steve Yoelin Medical Associates

Newport Beach, California, United States

Key Dates

Start Date

November 20, 2024

Primary Completion Date

July 1, 2025

Completion Date

August 1, 2025

Last Updated

May 13, 2025

Enrollment

ACTUAL participants

Conditions

Wrinkles in DecolletagePigmentationDécolleté Wrinkles

Interventions

KB304

BIOLOGICAL

0.9% Normal Saline (NS)

DRUG

The Effects of Almond on Facial Skin Collagen and Wrinkles

NCT06074276

Collagen DegenerationWrinkle+2 more

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RECRUITINGNA

Pilot Study of LED for PIE and PIH

NCT06349447

Hyperpigmentation

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RECRUITINGNA

Efficacy and Tolerability of Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study Assessing KB304 for the Treatment of Wrinkles in Women

Inclusion Criteria

Exclusion Criteria

The Effects of Almond on Facial Skin Collagen and Wrinkles

Pilot Study of LED for PIE and PIH

Efficacy and Tolerability of Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins

Macular Pigment Measurements in Eye & Other Tissues

COMPARISON OF EFFICACY AND SAFETY OF NARROWBAND UVB WITH 0.1% TACROLIMUS VS NARROWBAND UVB WITH 0.005% CALCIPOTRIOL IN TREATMENT OF VITILIGO

Oxygen Saturations Across Tones of Skin