NCT03036306

Dose Ranging Study to Evaluate the Safety and Tolerability of SCX-001 Cream in Healthy Volunteers With Induced Dermal Incisions

A Randomized, Placebo Controlled, Double-blind, Dose Ranging Study to Evaluate the Safety and Tolerability of SCX-001 Cream in Healthy Volunteers With Induced Dermal Incisions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: ScarX Corp · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and local tolerability of two different concentrations of of SCX-001 cream, as compared to placebo, when topically applied twice a day for 21 days to artificially induced dermal wounds in healthy volunteers. In addition, the absorption and elimination of profiles of this topically applied product will be determined through pharmacokinetic sampling. Assessments for effect of SCX-001 vs. placebo will be done but are considered exploratory.

Conditions

• Scarring

Interventions

Type	Name	Description
DRUG	SCX-001	Nefopam cream formulation
OTHER	Placebo	Cream formulation without Nefopam

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-10-02
• Completion: 2017-10-02
• First posted: 2017-01-30
• Last updated: 2017-10-04

Locations

1 site across 1 country: Canada