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

19 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment KB304 for neck wrinkles?

The research suggests that treatments like botulinum toxin type A and other topical products with active ingredients such as retinol and hyaluronic acid have shown effectiveness in reducing neck wrinkles and improving skin appearance. These findings may indirectly support the potential effectiveness of KB304 if it contains similar components or mechanisms. ^{1 2 3 4 5}

How is the treatment KB304 different from other treatments for neck wrinkles?

The research does not provide specific information about KB304, so it's unclear how it differs from other treatments for neck wrinkles. ^{2 6 7 8 9}

What is the purpose of this trial?

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 Criteria

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

I have moderate to severe wrinkles on my chest area.

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 am willing to follow the study's birth control requirements.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of a retinol containing topical treatment to improve signs of neck aging. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The Aesthetic Concerns of Botulinum Toxin Type A in the Treatment of Neck Wrinkles: A Systematic Review. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Assessment of a Comprehensive Anti-Aging Neck Cream. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

IncobotulinumtoxinA for the treatment of platysmal bands: a single-arm, prospective proof-of-concept clinical study. [2014]

5. England 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. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Sagittal skin contour of the cervical spine: interexaminer and intraexaminer reliability of the flexicurve instrument. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Tolerability of a Novel Topical Treatment for Neck: A Randomized, Double-blind, Regimen-Controlled Study. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Treatment of Horizontal Neck Wrinkles with Hyaluronic Acid Filler: A Retrospective Case Series. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Subdermal minimal surgery with hyaluronic acid as an effective treatment for neck wrinkles. [2014]