drugset / Trial / NCT01612221

Oral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo

NCT01612221

Phase 2 Completed 100 enrolled University of Utah
RandomizedParallel-groupTriple-blindPrevention

Summary

This is a phase II intervention to propose a new melanoma chemoprevention agent. The investigators believe oxidative stress/damage in nevi is a probable indication for melanoma risk, and propose that reduced melanoma risk in humans can be inferred by protection of nevi from ultraviolet light (UV)-induced oxidative changes. The investigators will 1) evaluate whether administration of NAC around the time of UV exposure will reduce melanoma risk in high-risk patient populations with genetic susceptibility to UV-induced oxidative stress, and 2) examine key genetic variants that will identify which individuals are most likely to benefit from chemoprotection.

Timeline

Start
2012-09
Primary completion
2016-02
Completion
2016-02

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 1200 mg Oral