The Safety of Topically Delivered FS2 in Humans. Phase 1 Clinical Trial

NCT02340325 Phase 1 COMPLETED

Background Scarring typically occurs after trauma, burn injury or surgery. Hypertrophic scarring presents as raised, red and itchy lesions which variably respond to various treatment modalities, such as corticosteroids, pressure garments, laser therapy, the use of silicone sheets and radiotherapy. Kynurenine, or "Fibrostop 1" (FS1), and its further breakdown products, such as kynurenic acid, or "Fibrostop 2" (FS2), are endogenous products found in many systems and have shown potential in reducing scar formation in animal studies. The aim of study is to evaluate the safety and tolerability of FS2 cream applied to the skin of healthy human subjects.

Details

Lead sponsor	British Columbia Professional Firefighters' Burn and Wound Healing Laboratory
Phase	Phase 1
Status	COMPLETED
Enrolment	20
Start date	2015-05
Completion	2016-01

Conditions

• Cicatrix
• Cicatrix, Hypertrophic
• Keloid

Interventions

• Acute Application of kynurenic acid cream
• Chronic application of kynurenic acid cream

Primary outcomes

• Acute skin irritation or local reaction — 24 hours
  After application of various concentrations of the active substance, patients will be evaluated at 24 hours post application for skin reactions and adverse reactions by a blinded observer

Countries

Canada