drugset / Trial / NCT02340325

FS2 Safety and Tolerability Study in Healthy Volunteers

NCT02340325 ↗

RandomizedSingle-groupTriple-blindTreatment

Summary

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.

Timeline

Start
2015-05
Primary completion
2016-01
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Subject kynurenic acid Unknown 0.15 % Topical
Subject kynurenic acid Unknown 0.25 % Topical
Subject kynurenic acid Unknown 0.4 % Topical
Subject kynurenic acid Unknown 0.5 % Topical

Indications