NCT05501327|RecruitingPhase 2FDA Drug
Dose Regimen Study of SLI-F06 in Healthy Volunteers
A Randomized, Within Subject Controlled, Dose Regimen Study of SLI-F06 in Healthy Volunteers for Improvement in Scar Appearance
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Sponsor study identifier
interventional
30
1 country
2
Study Start
July 25, 2022
Actual (reported)Primary Completion
July 25, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 25, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 25, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 25, 2022
Actual (reported)August 11, 2022
Actual (reported)August 15, 2022
Actual (reported)July 25, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 25, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Months 1,3,6 and possibly 9
Patient and Observer Scar Assessment Scale (POSAS) Observer Scale
Months 1,3,6 and possibly 9
Scarless Labs Patient Scale
Months 1,3,6 and possibly 9
Injection of SLI-F06 on Treatment Day 0, immediately after wound closure: * Formulation buffer (control) * 3.75 mg SLI-F06 total dose per wound (1X) * 7.5 mg SLI-F06 total dose per wound (2X) * 15 mg SLI-F06 total dose per wound (4X)
Injection of SLI-F06 on Treatment Day 0, immediately after wound closure and on Days 1, 2, 3, 4: * Formulation buffer (control) * 3.75 mg SLI-F06 total dose per wound (1X) * 7.5 mg SLI-F06 total dose per wound (2X) * 15 mg SLI-F06 total dose per wound (4X)
Skin injection of SLI-F06 at each wound edge after closure of punch biopsy excision.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
California Dermatology & Clinical Research Institute
Encinitas, California, 92024, United States
DermResearch
Austin, Texas, 78759, United States
Elisabeth J Leeflang, MD
Scarless Laboratories, Inc.
First Submitted
August 11, 2022
First Posted
August 15, 2022
Study Start
July 25, 2022
Actual (reported)Primary Completion
July 25, 2024
Estimated (date passed)Investigation of the Accelerated Healing and Anti-scarring Potential of Avotermin (Juvista) in Split Skin Graft Donor Sites
Injection of SLI-F06 on Treatment Day 0, immediately after wound closure and then 3 hours after for wounds dosed twice: * Formulation buffer (control) once * 7.5 mg SLI-F06 total dose per wound (2X) once * 3.75 mg SLI-F06 dose per wound (1X) twice, total dose 7.5 mg * 7.5 mg SLI-F06 total dose per wound (2X), total dose 15 mg
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 25, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 27, 2023
Record last verified: 2023-07
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Source: ClinicalTrials.gov.
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