RECRUITING

Dose Regimen Study of SLI-F06 in Healthy Volunteers

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Randomized, Within Subject Controlled, Dose Regimen Study of SLI-F06 in Healthy Volunteers for Improvement in Scar Appearance

Quick Facts

Study Start:2022-07-25

Study Completion:2024-10-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05501327

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Healthy subjects, male or female, ages 18 to 65 2. Subjects with a Body Mass Index (BMI) 18.5-30 and at least 40 kg 3. Subjects 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. 4. Be able to follow study instructions and likely to complete all required visits. 5. 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.	1. Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control methods 2. Subjects who were previously treated with SLI-F06 3. Subjects with evidence of hypertrophic or keloid scarring 4. Subjects with obvious back abnormalities (e.g., severe scoliosis) 5. Subjects with tattoos or previous scars in the study areas 6. Subjects who are poor surgical candidates 1. Active disease that could interfere with or limit wound healing (e.g., diabetes, anemia, renal disease, hepatic disease, cardiac disease, or immune system disorders) 2. History of clinically significant bleeding disorder or coagulation disorders 3. Use of any tobacco/inhaled nicotine products including vaping within 12 months. 7. Subjects with evidence of skin infection or rash on the back 8. Subjects 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 9. Subjects with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine or allergy to adhesive surgical dressings 10. Subjects with any clinically significant abnormality following review of pre-study laboratory data and full physical examination 11. Subjects who are taking or have taken known anticoagulants: 1. Blood thinners (e.g., coumadin, rivaroxaban, apixaban) within 2 months prior to day 0 2. 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. 12. Subjects taking systemic or topical steroids within 4 weeks of Day 0 13. Subjects 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) 14. Subjects who have evidence of drug abuse 15. Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B surface antigen per medical history 16. Subjects with a history of poor or delayed wound healing (e.g., prior wound dehiscence, chronic wound, leg ulcer) 17. Subjects treated with an investigational drug or device within 30 days prior to day 0 18. 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

Inclusion Criteria

Exclusion Criteria

1. Healthy subjects, male or female, ages 18 to 65
2. Subjects with a Body Mass Index (BMI) 18.5-30 and at least 40 kg
3. Subjects 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.
4. Be able to follow study instructions and likely to complete all required visits.
5. 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.

1. Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control methods
2. Subjects who were previously treated with SLI-F06
3. Subjects with evidence of hypertrophic or keloid scarring
4. Subjects with obvious back abnormalities (e.g., severe scoliosis)
5. Subjects with tattoos or previous scars in the study areas
6. Subjects who are poor surgical candidates
1. Active disease that could interfere with or limit wound healing (e.g., diabetes, anemia, renal disease, hepatic disease, cardiac disease, or immune system disorders)
2. History of clinically significant bleeding disorder or coagulation disorders
3. Use of any tobacco/inhaled nicotine products including vaping within 12 months.
7. Subjects with evidence of skin infection or rash on the back
8. Subjects 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
9. Subjects with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine or allergy to adhesive surgical dressings
10. Subjects with any clinically significant abnormality following review of pre-study laboratory data and full physical examination
11. Subjects who are taking or have taken known anticoagulants:
1. Blood thinners (e.g., coumadin, rivaroxaban, apixaban) within 2 months prior to day 0
2. 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.
12. Subjects taking systemic or topical steroids within 4 weeks of Day 0
13. Subjects 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)
14. Subjects who have evidence of drug abuse
15. Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B surface antigen per medical history
16. Subjects with a history of poor or delayed wound healing (e.g., prior wound dehiscence, chronic wound, leg ulcer)
17. Subjects treated with an investigational drug or device within 30 days prior to day 0
18. 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

Contacts and Locations

Study Contact

Elisabeth J Leeflang, MD

CONTACT

213-788-2128

ELeeflang@scarlesslabs.com

Principal Investigator

Elisabeth J Leeflang, MD

STUDY_DIRECTOR

Scarless Laboratories, Inc.

Study Locations (Sites)

California Dermatology & Clinical Research Institute

Encinitas, California, 92024

United States

DermResearch

Austin, Texas, 78759

United States

Collaborators and Investigators

Sponsor: Scarless Laboratories, Inc.

Elisabeth J Leeflang, MD, STUDY_DIRECTOR, Scarless Laboratories, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-25

Study Completion Date2024-10-25

Study Record Updates

Study Start Date2022-07-25

Study Completion Date2024-10-25

Terms related to this study

Keywords Provided by Researchers

Scar
Scar Appearance
Wound Healing

Additional Relevant MeSH Terms

Scar
Wound Healing