NCT03880058

Safety and Efficacy of SLI-F06 in Wound Healing and Scar Appearance

Safety and Efficacy of SLI-F06 in Wound Healing and Scar Appearance in Pre-Abdominoplasty Surgical Excisions and Post-Operative Scar Appearance In Subjects Undergoing Abdominoplasty

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Scarless Laboratories, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, double-blind study comparing SLI-F06 to vehicle formulation buffer for the improvement in scar appearance and wound strength in routine surgical excisions, as well as post-operative abdominoplasty scar appearance.

Detailed description

The study is divided into 2 parts where Part A is a Phase I safety/proof of concept study of small scars pre-abdominoplasty, and Part B is a Phase IIa study of post-abdominoplasty scars. In Part A of the study, subjects will have their abdominoplasty site mapped to accommodate a series of excisions depending on pannus size. All excisions to be treated with SLI-F06 will be on one side of the mapped area (i.e., left side or right side) and vehicle treated excisions will be on the other side of the mapped area. At time of abdominoplasty the excision site will be harvested and processed. In Part B of the study, subjects who complete Part A will be randomly assigned to receive injections of SLI-F06 along one half (left or right) of the abdominoplasty incision and control injections along the other half. The subject will undergo routine wound care and will attend study follow-up visits following abdominoplasty. The entire incision will be treated post-operatively in precisely the same manner. Duration of study-approximately 26 months.

Conditions

• Scars

Interventions

Type	Name	Description
DRUG	SLI-F06	Active treatment
DRUG	Formulation buffer	Placebo treatment

Timeline

• Start date: 2019-03-03
• Primary completion: 2021-05-18
• Completion: 2021-05-18
• First posted: 2019-03-19
• Last updated: 2023-04-18
• Results posted: 2023-04-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study