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New treatment option for Scar
Official title Dose Regimen Study of SLI-F06 in Healthy Volunteers
ClinicalTrials.gov ID: NCT05501327
What this study is testing
What is SLI-F06?
SLI-F06 is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for scar.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Multi-center, dose-regimen, double-blind study evaluating the safety and efficacy of 4 doses of SLI-F06 compared with vehicle for improvement in scar appearance
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Healthy people, male or female, ages 18 to 65
- people with a Body Mass Index (BMI) 18.5-30 and at least 40 kg
- people with symmetrically located right and left scapular lines relative to the midline, and at least 12 cm distance between the right and left...
- Be able to follow study instructions and likely to complete all required visits.
- Sign the Institutional Review Board (IRB)-approved informed consent form (ICF, which includes the Photographic and Video Release Form) prior to any...
You likely can't join if
- Female people who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control methods
- people who were previously treated with SLI-F06
- people with evidence of hypertrophic or keloid scarring
- people with obvious back abnormalities (e.g., severe scoliosis)
- people with tattoos or previous scars in the study areas
- people who are poor surgical candidates
See the full eligibility criteria
- Healthy people, male or female, ages 18 to 65
- people with a Body Mass Index (BMI) 18.5-30 and at least 40 kg
- people with symmetrically located right and left scapular lines relative to the midline, and at least 12 cm distance between the right and left scapular lines.
- Be able to follow study instructions and likely to complete all required visits.
- Sign the Institutional Review Board (IRB)-approved informed consent form (ICF, which includes the Photographic and Video Release Form) prior to any study-related procedures being performed.
- Female people who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control methods
- people who were previously treated with SLI-F06
- people with evidence of hypertrophic or keloid scarring
- people with obvious back abnormalities (e.g., severe scoliosis)
- people with tattoos or previous scars in the study areas
- people who are poor surgical candidates
- Active disease that could interfere with or limit wound healing (e.g., diabetes, anemia, renal disease, hepatic disease, cardiac disease, or immune system disorders)
- History of clinically significant bleeding disorder or coagulation disorders
- Use of any tobacco/inhaled nicotine products including vaping within 12 months.
- people with evidence of skin infection or rash on the back
- people with history of active or uncontrolled skin disease (e.g., psoriasis, eczema, rosacea, vitiligo, skin cancer) that could interfere with the study or interpretation of the study outcomes
- people with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine or allergy to adhesive surgical dressings
- people with any clinically significant abnormality following review of pre-study laboratory data and full physical examination
- people who are taking or have taken known anticoagulants:
- Blood thinners (e.g., coumadin, rivaroxaban, apixaban) within 2 months prior to day 0
- Others such as aspirin or aspirin containing products, Non-steroidal anti-inflammatory drugs (NSAIDs), vitamin E, fish oil within 14 days prior to day 0.
- people taking systemic or topical steroids within 4 weeks of Day 0
- people with excessive alcohol use, defined as \>28 units of alcohol per week (1unit = 8 g alcohol, 1shot spirits, half- pint beer, or 5 oz wine)
- people who have evidence of drug abuse
- people who are known to have or had serum hepatitis or who are carriers of the hepatitis B surface antigen per medical history
- people with a history of poor or delayed wound healing (e.g., prior wound dehiscence, chronic wound, leg ulcer)
- people treated with an investigational drug or device within 30 days prior to day 0
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, or may significantly interfere with the subject's participation in the study
The study team makes the final eligibility decision.
Where it's taking place
- Encinitas, California, United States
- Austin, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Encinitas, California, United States; Austin, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.