SLI-F06 for Scarring

California Dermatology & Clinical Research Institute, Encinitas, CA
Scarring+1 More ConditionsSLI-F06 - Drug
Eligibility
18 - 65
All Sexes

Study Summary

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

Eligible Conditions
  • Scarring
  • Wound Healing

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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1
BIAKOS™ Antimicrobial Skin & Wound Cleanser, BIAKŌS Antimicrobial Wound Gel
1
Biweekly IV Gentamicin
2
Sofwave

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Months 1,3,6 and possibly 9

Month 6
POSAS Observer Scale
Scarless Labs Observer Scale
Month 1
Change in Scarless Labs Observer Scale
Patient and Observer Scar Assessment Scale (POSAS) Observer Scale
Scarless Labs Patient Scale

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
BIAKOS™ Antimicrobial Skin & Wound Cleanser, BIAKŌS Antimicrobial Wound Gel
1
Biweekly IV Gentamicin
3
Sofwave

Side Effects for

SLI-F06
9%Cellulitis
9%Nasopharyngitis
5%Nephrolithiasis
5%Pneumonia
5%Wound dehiscence
5%Drain site complication
5%Seroma
5%Sinus tachycardia
5%Aortic arteriosclerosis
5%Urinary tract infection
5%Influenza like illness
5%Vomiting
5%Alopecia
5%Constipation
5%Dermatitis allergic
5%Chest pain
5%Hypersensitivity
5%Seroma drainage
5%Umbilical hernia
5%Influenza
5%Pyrexia
5%Dermoid cyst
5%Ascites
5%Flatulence
5%Pulmonary embolism
5%Skin necrosis
5%Synovial cyst
5%Tendonitis
5%Incision site hemorrhage
5%Abortion spontaneous
5%Headache
5%Abdominal hernia
5%Atelectasis
5%Allergy to surgical sutures
5%Tension headache
5%Contusion
5%Impaired healing
5%Nausea
5%Dermatitis contact
5%Skin irritation
This histogram enumerates side effects from a completed 2021 Phase 1 & 2 trial (NCT03880058) in the SLI-F06 ARM group. Side effects include: Cellulitis with 9%, Nasopharyngitis with 9%, Nephrolithiasis with 5%, Pneumonia with 5%, Wound dehiscence with 5%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

3 Treatment Groups

Cohort A
1 of 3
Cohort B
1 of 3
Cohort C
1 of 3

Experimental Treatment

30 Total Participants · 3 Treatment Groups

Primary Treatment: SLI-F06 · No Placebo Group · Phase 2

Cohort A
Drug
Experimental Group · 1 Intervention: SLI-F06 · Intervention Types: Drug
Cohort B
Drug
Experimental Group · 1 Intervention: SLI-F06 · Intervention Types: Drug
Cohort C
Drug
Experimental Group · 1 Intervention: SLI-F06 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SLI-F06
2019
Completed Phase 2
~30

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: months 1,3,6 and possibly 9

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.

Eligibility Criteria

Age 18 - 65 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You weigh between 88 and 220 pounds and have a healthy body mass index (BMI) between 18.5 and 30.
Your shoulder blades are evenly spaced apart and at least 12 centimeters apart from each other.

Who else is applying?

What state do they live in?
California100.0%
What site did they apply to?
California Dermatology & Clinical Research Institute100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "I have healed surgical scars that are embarrassing"
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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