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
The is a Phase IIa dose-regimen study of small punch biopsy scars created on the upper and lower back of healthy patients. All excisions will be randomized to treatment with vehicle or 4 doses of SLI-F06 drug product. Patients will be divided into 3 cohorts, with Cohort B receiving the same doses as Cohort A but daily for a total of 5 days. Cohort C will receive up to twice the concentration of Cohort A potentially divided into 2 doses, with both cohorts treated only on treatment Day 0. Scars will be assessed for improvement by both the investigator and the patient at follow-up visits over 6-9 months. Duration of study-approximately 7-10 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Skin injection of SLI-F06 at each wound edge after closure of punch biopsy excision.
California Dermatology & Clinical Research Institute
Encinitas, California, United States
RECRUITINGDermResearch
Austin, Texas, United States
RECRUITINGChange 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 9
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 9
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 9
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.