NCT05271708

Explore the Short- and Mid-term Effects of Fespixon in Scar Cosmesis Following Cervical or Abdominal Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: National Defense Medical Center, Taiwan · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the efficacy of the Fespixon cream for prevention and/or appearance reduction of different types of linear scars during the 12-week treatment phase, which is assessed by the blinded independent evaluator.

Detailed description

Methods: This study was designed as a prospective, double-blind, placebo-controlled trial involving 50 patients with linear scars. Bounded by the midpoint of the scar, each patient received a topical scar formulation consisting of fespixon cream on one side of scar, and placebo cream on the other side of scar. Treatment was given twice a day for 84 days. Assessments of the scars were performed at visit 1, 2, 3 following the onset of topical application using three methods: a clinical assessment using the Vancouver Scar Scale/ modified Vancouver Scar Scale, a photographic assessment to establish before and after treatment improvements, and at the end of the study period, patients completed a final satisfaction questionnaire.

Conditions

• Scar

Interventions

Type	Name	Description
DRUG	Fespixon cream	Bounded by the midpoint of the scar, each patient received two topical scar formulations consisting of Fespixon cream on one side, and placebo cream on the other side. Treatment was given twice a day for 84 days.
DRUG	Placebo Cream	Bounded by the midpoint of the scar, each patient received two topical scar formulations consisting of Fespixon cream on one side, and placebo cream on the other side. Treatment was given twice a day for 84 days.

Timeline

• Start date: 2022-01-05
• Primary completion: 2022-10-17
• Completion: 2022-11-30
• First posted: 2022-03-09
• Last updated: 2022-12-28

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study