A Study Evaluating Nexagon™ in the Treatment of Skin Wounds.
Nexagon™ is a novel compound that promotes wound healing by temporarily disrupting cellular communication at the wound site, thereby promoting accelerated healing, reducing inflammation and pain. This randomized double-blind study will assess the safety, tolerability and clinical effect of Nexagon™ when applied to skin wounds created by punch biopsy in healthy volunteers. 43 healthy, fair-skinned males and females between ages 18-40 will be enrolled. Subjects will be reviewed again at 3 months and 9 months for follow-up safety assessments and wound appearance evaluation.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 1 Randomized, Prospective, Within-Subject, Double-Blind, Vehicle-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability and Clinical Effect of Nexagon™ in Full-Thickness Punch Wounds|
- Assessed by the incidence of adverse events from the time of application of the investigational product [ Time Frame: Until the end of the study. ] [ Designated as safety issue: Yes ]
- Time to complete closure of the wounds [ Time Frame: 35 days post-application ] [ Designated as safety issue: No ]
- Rate of healing [ Time Frame: 35 days post application ] [ Designated as safety issue: No ]
- Clinical assessment by rating scales [ Time Frame: 35 days post application ] [ Designated as safety issue: No ]
- Pain [ Time Frame: 35 days post application ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Study Completion Date:||April 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|