Dose Regimen Study of SLI-F06 in Healthy Volunteers
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorScarless Laboratories, Inc.
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy subjects, male or female, ages 18 to 65
Subjects with a Body Mass Index (BMI) 18.5-30 and at least 40 kg
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.
Be able to follow study instructions and likely to complete all required visits.
Disqualifiers
Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control methods
Subjects who were previously treated with SLI-F06
Subjects with evidence of hypertrophic or keloid scarring
Subjects with obvious back abnormalities (e.g., severe scoliosis)
Trial design
Design model
Parallel
Treatments tested in this trial
SLI-F06
DrugSkin injection of SLI-F06 at each wound edge after closure of punch biopsy excision.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Cohort AExperimental treatment 1 intervention
Group B: Cohort BExperimental treatment 1 intervention
Group C: Cohort CExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Scarless Labs Observer Scale
Exploratory scale for observer to assess different scar parameters, including Surface Area, Elevation / Depression, Relief, Thickness, Pliability, Vascularity and Pigmentation. The observer then makes an Overall global assessment (scale 0 to -3) of the scar based on the clinical assessment of the scar parameters. All parameters are assessed on a scale of 0-3 (except pigmentation, -3 \[hypo\] to +3 \[hyper\]), where 0 correlates to a scar that is indistinguishable from normal skin with greater deviation from 0 correlating with more severe scar. The observer creates a forced rank between scars on the upper and lower back based on best (1) to worst (4) cosmetically.
Time frame
Months 1,3,6 and possibly 9Secondary outcomes
1
Patient and Observer Scar Assessment Scale (POSAS) Observer Scale
Established scar scale with observer rating of 1 (normal skin) to 10 (worst scar imaginable) for 6 different parameters (vascularity, pigmentation, thickness, relief, pliability, surface area) and overall opinion rated on the same 1-10 scale. The sum of these scores is added for a total value with a higher number being worse.
Time frame
Months 1,3,6 and possibly 92
Scarless Labs Patient Scale
Exploratory scale for subjects to assess different scar parameters, with 0 being no difference in pain or itching of the scar compared with normal skin and -3 being severe or worse. Patients then select a face on a modified Wong-Baker scale for their overall opinion of the scar.
Time frame
Months 1,3,6 and possibly 9Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov