What side effects are associated with this type of intervention?

Common treatments for scarring, such as cryotherapy, intense pulsed light (IPL), and laser therapies, have various side effects. Cryotherapy can lead to significant decreases in scar height and improvements in color and pliability but may cause discomfort and temporary skin discoloration. IPL and laser treatments, while effective for reducing vessel diameter and improving skin texture, can result in purpura (bruising), pigmentary alterations, blistering, and erythema. Nonablative fractional lasers, used for skin rejuvenation, generally have low risks for serious adverse effects but may cause mild erythema and temporary skin sensitivity.

What prior FDA approvals exist?

FDA-approved treatments for scarring include various topical agents, injectable fillers, and laser therapies. Topical treatments such as silicone gels and sheets are commonly used to improve scar appearance. Injectable fillers, like hyaluronic acid, have also been approved for the treatment of certain types of scars by adding volume and smoothing the skin. Additionally, laser therapies, including fractional CO2 lasers, have been approved for their efficacy in reducing scar visibility by promoting collagen remodeling and skin resurfacing.

What other types of research exist?

Promising alternatives to SLI-F06 for scar improvement include: 1) Picosecond lasers, which have shown success in treating pigmentary lesions and may be effective for scars. 2) Nonthermal laser-induced optical breakdown technology, which offers significant improvements in skin texture and appearance without damaging the epidermis. 3) Intense Pulsed Light (IPL) therapy, particularly when combined with a topical photosensitizer, which can enhance skin texture and pigmentation. These options provide effective, minimally invasive treatments for scarring.

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Unknown

SLI-F06 for Scarring

Phase 2

Recruiting

Research Sponsored by Scarless Laboratories, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 1,3,6 and possibly 9

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medication called SLI-F06 to see if it can improve the appearance of scars. Healthy individuals with small biopsy scars on their backs will receive different doses of the medication. The goal is to find out if SLI-F06 helps scars heal better and look less noticeable over time.

Who is the study for?

Healthy men and women, aged 18-65 with a BMI of 18.5-30, can join this trial if they have symmetrical scapular lines and are able to follow the study's instructions. They must not have used SLI-F06 before or any blood thinners recently, be free from significant health issues that affect healing, not pregnant or breastfeeding without reliable birth control, no excessive alcohol use or tobacco products in the past year.

What is being tested?

The study is testing four different doses of SLI-F06 against a placebo to see which one is better at improving scar appearance after surgery. It's conducted across multiple centers where participants are randomly assigned to receive either the drug or placebo without knowing which one they're getting (double-blind).

What are the potential side effects?

Potential side effects aren't specified but may include typical reactions related to skin treatments such as redness, irritation at the application site, allergic reactions including hypersensitivity to lignocaine or adhesive dressings.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 1,3,6 and possibly 9

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 1,3,6 and possibly 9

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 1,3,6 and possibly 9 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Scarless Labs Observer Scale

Secondary study objectives

Patient and Observer Scar Assessment Scale (POSAS) Observer Scale

Scarless Labs Patient Scale

Side effects data

From 2021 Phase 1 & 2 trial • 22 Patients • NCT03880058

Cellulitis

Nasopharyngitis

Nausea

Urinary tract infection

Tension headache

Hypersensitivity

Contusion

Vomiting

Skin irritation

Wound dehiscence

Pulmonary embolism

Abortion spontaneous

Nephrolithiasis

Seroma drainage

Umbilical hernia

Alopecia

Skin necrosis

Seroma

Pyrexia

Headache

Aortic arteriosclerosis

Abdominal hernia

Pneumonia

Dermoid cyst

Ascites

Atelectasis

Synovial cyst

Sinus tachycardia

Chest pain

Allergy to surgical sutures

Tendonitis

Influenza like illness

Dermatitis allergic

Influenza

Flatulence

Constipation

Impaired healing

Dermatitis contact

100%

80%

60%

40%

20%

Study treatment Arm

Formulation Buffer

SLI-F06

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort CExperimental Treatment1 Intervention

Injection of SLI-F06 on Treatment Day 0, immediately after wound closure and then 3 hours after for wounds dosed twice: * Formulation buffer (control) once * 7.5 mg SLI-F06 total dose per wound (2X) once * 3.75 mg SLI-F06 dose per wound (1X) twice, total dose 7.5 mg * 7.5 mg SLI-F06 total dose per wound (2X), total dose 15 mg

Group II: Cohort BExperimental Treatment1 Intervention

Injection of SLI-F06 on Treatment Day 0, immediately after wound closure and on Days 1, 2, 3, 4: * Formulation buffer (control) * 3.75 mg SLI-F06 total dose per wound (1X) * 7.5 mg SLI-F06 total dose per wound (2X) * 15 mg SLI-F06 total dose per wound (4X)

Group III: Cohort AExperimental Treatment1 Intervention

Injection of SLI-F06 on Treatment Day 0, immediately after wound closure: * Formulation buffer (control) * 3.75 mg SLI-F06 total dose per wound (1X) * 7.5 mg SLI-F06 total dose per wound (2X) * 15 mg SLI-F06 total dose per wound (4X)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SLI-F06

2019

Completed Phase 2

~30

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for scarring, such as those being studied in the SLI-F06 trial, often focus on improving the appearance of scars through various mechanisms. Nonablative fractional laser therapies work by creating controlled micro-injuries in the skin, which stimulate collagen production and remodeling, leading to smoother and less visible scars. Injectable fillers, like hyaluronic acid, temporarily fill in depressed scars, providing immediate improvement in texture and appearance. Topical agents, including silicone gels and corticosteroids, help to flatten and soften raised scars by modulating collagen synthesis and reducing inflammation. These treatments are crucial for scarring patients as they offer multiple approaches to enhance skin texture, reduce scar visibility, and improve overall skin aesthetics, thereby boosting patient confidence and quality of life.

Treatment response of keloidal and hypertrophic sternotomy scars: comparison among intralesional corticosteroid, 5-fluorouracil, and 585-nm flashlamp-pumped pulsed-dye laser treatments.