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

ClinicalTrials.gov · COMPLETED, 2016

20 participants

Abstract

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.

Conditions: Cicatrix, Cicatrix, Hypertrophic, Keloid.

Primary outcome: Acute skin irritation or local reaction.

Enrollment: 20 participants.

How strong is the evidence?

Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 20 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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