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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
Healthy subjects, male or female, ages 18 to 65
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 1,3,6 and possibly 9
Awards & highlights

Study Summary

This trial evaluated the safety and effectiveness of a new scar treatment compared to a placebo.

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.Check my eligibility
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).See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old and in good health.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Scarless Labs Observer Scale
Secondary outcome measures
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
9%
Cellulitis
9%
Nasopharyngitis
5%
Tension headache
5%
Contusion
5%
Urinary tract infection
5%
Hypersensitivity
5%
Vomiting
5%
Nausea
5%
Skin irritation
5%
Wound dehiscence
5%
Pulmonary embolism
5%
Abortion spontaneous
5%
Nephrolithiasis
5%
Seroma drainage
5%
Umbilical hernia
5%
Alopecia
5%
Skin necrosis
5%
Seroma
5%
Pyrexia
5%
Headache
5%
Aortic arteriosclerosis
5%
Abdominal hernia
5%
Pneumonia
5%
Dermoid cyst
5%
Ascites
5%
Atelectasis
5%
Synovial cyst
5%
Sinus tachycardia
5%
Chest pain
5%
Allergy to surgical sutures
5%
Tendonitis
5%
Influenza like illness
5%
Dermatitis allergic
5%
Influenza
5%
Flatulence
5%
Constipation
5%
Impaired healing
5%
Dermatitis contact
100%
80%
60%
40%
20%
0%
Study treatment Arm
Formulation Buffer
SLI-F06

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

Find a Location

Who is running the clinical trial?

Scarless Laboratories, Inc.Lead Sponsor
1 Previous Clinical Trials
22 Total Patients Enrolled
1 Trials studying Scarring
22 Patients Enrolled for Scarring
Elisabeth J Leeflang, MDStudy DirectorScarless Laboratories, Inc.

Media Library

SLI-F06 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05501327 — Phase 2
Scarring Research Study Groups: Cohort A, Cohort B, Cohort C
Scarring Clinical Trial 2023: SLI-F06 Highlights & Side Effects. Trial Name: NCT05501327 — Phase 2
SLI-F06 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05501327 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of recruitment for this research project?

"Affirmative. The information hosted on clinicaltrials.gov attests to the fact that this study is currently enrolling individuals for participation, with the original post being made July 25th 2022 and last revised August 24th 2022. For this trial, 30 guinea pigs are needed from a solitary medical centre."

Answered by AI

Who is eligible to take part in this research project?

"This clinical trial is seeking 30 participants aged between 18 and 65 with wound healing conditions. To qualify, patients must meet these criteria."

Answered by AI

What implications could SLI-F06 have on human health?

"Our team at Power has ranked the safety of SLI-F06 as a 2 since there is some evidence of its security, yet none indicating efficacy."

Answered by AI

Are there available slots for individuals to become participants in this experiment?

"According to clinicaltrials.gov, this experiment is still recruiting individuals for participation. The protocol was first posted on July 25th 2022 and the most recent changes were made August 24th 2022."

Answered by AI

Is the enrollment criteria for this trial inclusive of individuals aged 35 and over?

"According to the requirements of this trial, potential volunteers must be at least 18 years old and no older than 65."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
California Dermatology & Clinical Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Dose Regimen Study of SLI-F06 in Healthy Volunteers
2022. "Dose Regimen Study of SLI-F06 in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05501327.
~4 spots leftby Jul 2024
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