FS2 for Scarring from Burns

Overseen By Stephanie Recker

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Birch BioMed Inc

Disqualifiers: Pregnancy, Heavy smoking, Heavy drinking, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 148

70 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to see how an ingredient called kynurenic acid (which we named "FS2") affects scar formation in people with burn injuries that need skin graft surgery. A cream with FS2 will be used on both the area where the skin graft was placed and the area where the skin was taken (donor site). The cream will be applied after the skin has healed. This study will help us understand if FS2 is safe and effective for mitigating skin scar formation in burn patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment FS2 for scarring from burns?

Research shows that treatments like fractional ablative carbon dioxide laser therapy and basic fibroblast growth factor can improve the appearance and quality of burn scars. These therapies help by improving scar texture and reducing scar height and pigmentation, suggesting that FS2 might work similarly. ^{1 2 3 4 5}

Is FS2 safe for treating scarring from burns?

The research on treatments similar to FS2, like fibroblast growth factor, shows they are generally safe for use in humans, with no significant adverse events reported in studies involving burn treatments. ^{6 7 8 9 10}

How does the FS2 treatment for scarring from burns differ from other treatments?

FS2 is unique because it may involve the use of basic fibroblast growth factor (bFGF), which has been shown to significantly speed up the healing of second-degree burns compared to not using bFGF. This faster healing could potentially lead to less severe scarring. ^{1 3 11 12 13}

Research Team

Carlos Camozzi, MD, PHD

Principal Investigator

BirchBioMed Inc.

Eligibility Criteria

Adult burn patients aged 18-60 with a BMI of 15-35 kg/m2 who need skin grafts for burns, excluding the face and genitalia. Participants must be able to apply treatment creams themselves or with help, not smoke heavily, avoid heavy drinking or substance abuse recently, and have no history of keloid scarring or sensitivities to cream ingredients.

Inclusion Criteria

Clinically acceptable results in safety laboratory tests

I am willing and able to follow the study's requirements.

I am an adult who has suffered burns.

Exclusion Criteria

Recent participation in an interventional clinical trial

Heavy smoking (more than 20 cigarettes a day)

History of heavy drinking in the past month

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Blinded Treatment

Participants receive either the control cream or the FS2 cream for 90 days in a double-blind manner

12 weeks

Regular assessment visits including Day 28, Day 60, and Day 90

Open-label Treatment

All participants receive FS2 cream for an additional 90 days in an open-label period

12 weeks

Regular assessment visits including Day 120 and Day 180

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• FS2

Trial Overview The trial is testing a cream containing kynurenic acid (FS2) on scar formation after skin graft surgery in burn patients. The study compares FS2 cream's safety and effectiveness against a control cream when applied to both the grafted area and donor site post-healing.

Participant Groups

Group I: Skin Grafted wound Experimental Treatment 2 Interventions

The wound site (injury)

Group II: Donor Skin Graft Harvest wound Experimental Treatment 2 Interventions

A Surgical wound

Who Is Running the Clinical Trial?

Birch BioMed Inc

Lead Sponsor

Trials

1

Recruited

70+

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Collaborator

Trials

40

Recruited

2,400+

Findings from Research

A multicenter study involving 29 subjects with hypertrophic burn scars demonstrated that fractional ablative CO2 laser treatment significantly improved the elasticity, thickness, and overall appearance of scars, with objective measures showing improvements at a statistically significant level (P < 0.01).

Patient-reported outcomes also indicated significant reductions in pain and pruritus, and these improvements were sustained for at least 6 months after the treatment, highlighting the efficacy and lasting benefits of this laser therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional Ablative Laser Therapy is an Effective Treatment for Hypertrophic Burn Scars: A Prospective Study of Objective and Subjective Outcomes. Miletta, N., Siwy, K., Hivnor, C., et al.[2022]

In a study of 170 burn patients undergoing fractional CO2 laser therapy for hypertrophic scars, only 2.4% of treatment sessions resulted in adverse events, indicating that this therapy is generally safe.

Despite some minor side effects like increased pain and erythema, 97.1% of patients reported improvements in their scar symptoms, highlighting the efficacy of fractional CO2 laser therapy in managing hypertrophic burn scars.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Hypertrophic Burn Scars With Laser Therapy: A Review of Adverse Events. Won, P., Cooper, M., Gillenwater, TJ., et al.[2023]

Fractional carbon dioxide laser treatment significantly improved the quality of postburn scars in patients with skin phototypes III to VI, with average scores increasing from 4.4 to 7.33 for physicians and from 5.35 to 7.5 for patients after one year.

While 60% of patients experienced mild hypochromia two months post-treatment, this decreased to only 15% after one year, indicating that while hypopigmentation can occur, it often resolves over time, especially in patients with darker skin types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional Carbon Dioxide Laser in Patients with Skin Phototypes III to VI and Facial Burn Sequelae: 1-Year Follow-Up. Salles, AG., Luitgards, BF., Moraes, LB., et al.[2021]

Ablative carbon dioxide fractional laser treatment applied 2 to 3 weeks after thyroid surgery significantly improved the appearance of scars, as indicated by lower Vancouver Scar Scale scores in 23 women.

The treatment was found to be both effective and safe, with 12 out of 23 participants showing over 51% clinical improvement in scar appearance three months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early postoperative treatment of thyroidectomy scars using a fractional carbon dioxide laser. Jung, JY., Jeong, JJ., Roh, HJ., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Carbon dioxide laser treatment of burn-related scarring: Results of the ELIPSE (Early Laser Intervention Promotes Scar Evolution) prospective randomized controlled trial. [2023]

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

Hypertrophic scarring: the greatest unmet challenge after burn injury. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Carbon dioxide laser treatment in burn-related scarring: A prospective randomised controlled trial. [2022]

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

Fractional Ablative Laser Therapy is an Effective Treatment for Hypertrophic Burn Scars: A Prospective Study of Objective and Subjective Outcomes. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The quality of pediatric burn scars is improved by early administration of basic fibroblast growth factor. [2022]

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

Treatment of Hypertrophic Burn Scars With Laser Therapy: A Review of Adverse Events. [2023]

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

Effects of basic fibroblast growth factor on the healing of partial-thickness donor sites. A prospective, randomized, double-blind trial. [2006]

8. England pubmed.ncbi.nlm.nih.gov

Third-degree burn mouse treatment using recombinant human fibroblast growth factor 2. [2022]

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

Fractional Carbon Dioxide Laser in Patients with Skin Phototypes III to VI and Facial Burn Sequelae: 1-Year Follow-Up. [2021]

10. China pubmed.ncbi.nlm.nih.gov

[Significance of the secreted frizzled-related protein 2 expression in earlobe keloid]. [2010]

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

Basic fibroblast growth factor accelerates and improves second-degree burn wound healing. [2009]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of ablative fractional CO2 laser for the treatment of burn scars: A case-control study. [2022]

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

Early postoperative treatment of thyroidectomy scars using a fractional carbon dioxide laser. [2022]