KB304 for Neck Wrinkles

(Pearl-2 Trial)

Overseen By Brittani Agostini, RN

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: Krystal Biotech, Inc.

Disqualifiers: Skin conditions, Scars, Tattoos, others

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called KB304 to determine if it can safely and effectively reduce moderate to severe wrinkles in the chest area. KB304 is a gene therapy that promotes collagen and elastin production, proteins that keep skin smooth and firm. Participants will receive either the actual treatment or a placebo (inactive treatment) for comparison. Women with noticeable chest wrinkles and no interfering skin conditions might be suitable for this trial. As a Phase 1 and Phase 2 trial, this research aims to understand how KB304 works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to experience this innovative treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

Is there any evidence suggesting that KB304 is likely to be safe for humans?

Research has shown that KB304, a gene therapy for wrinkles, is generally well-tolerated. In earlier studies, patients reported low pain levels, averaging 2.4 out of 10 during treatment. Only minor side effects, such as redness and swelling, were observed, and these were temporary. This suggests that KB304 is safe to try, with most side effects being mild and short-lived. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for neck wrinkles, which often involve topical creams or injectable fillers, KB304 is unique because it uses a novel active ingredient designed to target the underlying causes of skin aging. Researchers are excited about KB304 because it potentially offers longer-lasting results by promoting collagen production, something traditional treatments don't directly address. Additionally, KB304 may provide a more natural-looking improvement in skin texture and elasticity, setting it apart from options that primarily focus on surface-level changes.

What evidence suggests that KB304 might be an effective treatment for neck wrinkles?

Research has shown that KB304 gene therapy offers promising results for treating neck wrinkles. In this trial, participants will receive either KB304 or a placebo. One study found that 81.8% of participants who received KB304 reported greater satisfaction with their wrinkles' appearance three months after treatment. KB304 also improved skin qualities such as firmness, moisture, and glow. The treatment boosts collagen and elastin, proteins that maintain skin firmness and elasticity. These early results suggest KB304 could help reduce moderate to severe wrinkles in the V-shaped chest area. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for women with moderate to severe wrinkles in the décolleté region. Participants should be healthy and looking to improve skin appearance. Specific eligibility details are not provided, but typically include age range and absence of certain health conditions.

Inclusion Criteria

Negative urine pregnancy test at Screening and Day 1 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

Fitzpatrick skin phototype score of I-IV

Exclusion Criteria

I do not have skin conditions near the study area that could affect the results.

I have scars, tattoos, or tanned skin in the area to be treated.

I have had surgery in the area being studied that could affect the trial's outcome.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive KB304 or placebo through intradermal injections to assess safety and efficacy for wrinkle treatment

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KB304

Trial Overview

The study tests KB304, a gene therapy aiming to reduce wrinkles by delivering collagen and elastin via injections. It's compared against a placebo (0.9% Normal Saline). The process is randomized and double-blind, meaning neither participants nor researchers know who receives which treatment.

How Is the Trial Designed?

Group I: KB304 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Krystal Biotech, Inc.

Lead Sponsor

Trials

15

Recruited

770+

Published Research Related to This Trial

A study involving 10 patients aged 35 to 65 showed that combining plasma exeresis with non-cross-linked hyaluronic acid (HA) injections significantly improved neck skin laxities, with 90% of patients reporting noticeable improvements according to the Global Aesthetic Improvement Scale (GAIS).

The treatment was well-tolerated, with a low average pain score of 2.4 out of 10 and only minor, transient side effects like erythema and edema, indicating a favorable safety profile for this combined approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synergic effect of plasma exeresis and non-cross-linked low and high molecular weight hyaluronic acid to improve neck skin laxities. Paganelli, A., Mandel, VD., Pellacani, G., et al.[2020]

A novel topical product combining retinol, tripeptide, and glaucine significantly improved signs of skin aging on the neck after 12 to 16 weeks of use, as evaluated through clinical assessments and participant feedback.

The treatment demonstrated statistically significant improvements in various aging attributes, including fine lines, wrinkles, skin laxity, and texture, supported by ultrasound imaging and skin biopsy biomarker analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a retinol containing topical treatment to improve signs of neck aging. Sullivan, K., Law, RM., Lain, E., et al.[2023]

In a study involving 23 subjects, incobotulinumtoxinA effectively reduced the appearance of platysmal bands, with 100% of participants showing improvement by Day 8 after treatment.

The treatment was well-tolerated with no serious adverse events reported, and subjects reported significant satisfaction with their results, particularly at maximum tension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IncobotulinumtoxinA for the treatment of platysmal bands: a single-arm, prospective proof-of-concept clinical study. Prager, W., Bee, EK., Havermann, I., et al.[2014]

A review of studies involving 112 women aged 24 to 65 indicates that Botulinum toxin type A (BTX-A) is likely effective for treating neck wrinkles, achieving high patient satisfaction rates without serious side effects.

While the evidence for BTX-A's aesthetic effects on neck wrinkles is not definitive, it shows promise as a treatment option, especially when used alone or in combination with other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Aesthetic Concerns of Botulinum Toxin Type A in the Treatment of Neck Wrinkles: A Systematic Review. Qiu, H., Zhao, R., Cao, L., et al.[2021]

The study involving 32 women showed that subdermal injection of CPM-HA significantly improves horizontal neck wrinkles, with results sustained for up to 36 weeks, indicating its long-term efficacy.

The treatment was found to be safe, with minimal adverse events reported, and the pain associated with blunt cannula use was higher than with sharp needle use, suggesting a consideration for injection technique in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Horizontal Neck Wrinkles with Hyaluronic Acid Filler: A Retrospective Case Series. Tseng, F., Yu, H.[2022]

In a study involving 12 Korean participants with horizontal neck wrinkles, subdermal minimal surgery technology was found to be effective, with over half of the participants showing at least a 50% improvement in wrinkle appearance two months after treatment.

The treatment was safe, as all participants completed the study without reported adverse effects, indicating its potential as a viable option for addressing neck wrinkles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subdermal minimal surgery with hyaluronic acid as an effective treatment for neck wrinkles. Han, TY., Lee, JW., Lee, JH., et al.[2014]

In a study of 85 adult females aged 35-65, a new neck cream applied twice daily for 3 months showed statistically significant improvements in hydration, texture, wrinkles, and laxity, with 94% of participants reporting improvements.

The number of participants who felt 'Satisfied' or 'Highly Satisfied' with the cream increased dramatically, indicating strong consumer approval and effectiveness in reducing visible signs of aging on the neck.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of a Comprehensive Anti-Aging Neck Cream. Saxena, SJ., Duque, D., Schirripa, MJ.[2019]

The flexicurve instrument demonstrated marginal reliability in measuring cervical sagittal skin contour, with most interexaminer correlation coefficients falling in the poor range (less than 0.40).

Intraexaminer reliability showed slightly better results, with some measurements reaching a fair range (0.4 to 0.5), indicating that while the flexicurve can be used, its consistency may be limited among different examiners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sagittal skin contour of the cervical spine: interexaminer and intraexaminer reliability of the flexicurve instrument. Harrison, DE., Haas, JW., Harrison, DD., et al.[2006]

A randomized, double-blind study showed that a novel topical cosmetic cream (NCC) significantly improved various signs of skin aging on the neck and décolletage, including sagging, wrinkles, and overall skin texture after twice daily application.

The cream's effectiveness is supported by mechanisms such as stimulating the production of collagen and elastin, as well as enhancing cellular processes that maintain skin health, as demonstrated in both clinical assessments and in vitro studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Tolerability of a Novel Topical Treatment for Neck: A Randomized, Double-blind, Regimen-Controlled Study. Makino, ET., Kadoya, K., Chung, R., et al.[2021]

Citations

1.

ir.krystalbio.com

ir.krystalbio.com/news-releases/news-release-details/jeune-announces-positive-results-and-significant-aesthetic

Jeune Announces Positive Results and Significant ...

As assessed by SSQ, 81.8% of subjects receiving KB304 reported improved satisfaction with their wrinkles' appearance three months after ...

2.

withpower.com

withpower.com/trial/kb304-for-neck-wrinkles-87704

KB304 for Neck Wrinkles (Pearl-2 Trial)

A study involving 10 patients aged 35 to 65 showed that combining plasma exeresis with non-cross-linked hyaluronic acid (HA) injections significantly improved ...

3.

trial.medpath.com

trial.medpath.com/news/47334586c04b5df0/krystal-biotech-s-kb304-gene-therapy-achieves-100-response-rate-in-phase-1-decollete-wrinkle-trial

Krystal Biotech's KB304 Gene Therapy Achieves 100 ...

KB304 showed broad improvements across multiple skin attributes including elasticity, hydration, and radiance, with 81.8% of patients reporting satisfaction ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06724900

A Study Assessing KB304 for the Treatment of Wrinkles in ...

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 ...

5.

jeuneinc.com

jeuneinc.com/wp-content/uploads/2025/07/KB304_PEARL-2_Results_for_Dynamic_Wrinkles_of_the_Decollete.pdf

KB304 PEARL-2 Results for Dynamic Wrinkles of the Décolleté

... wrinkles; the potential benefits of KB304's unique ... KB304 Designed to Increase Type III Collagen and Elastin Levels in Aging Skin.