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Oral NAC for UV-induced Oxidative Stress in Nevi
NCT01612221Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2012
- Primary completion
- Feb 2016
- Countries
- 1
- Sponsor
- University of Utah
- Modality
- Small Molecules
- Drugs
- acetylcysteine
- Conditions
- melanoma
01
Overview
Phase 2, randomised, double-blind trial in melanoma comparing N-acetylcysteine with Placebo (2 arms). Primary endpoint: UV-induced Oxidative Stress in Irradiated and Unirradiated Nevi at 3.5 years. Started Sep 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
N-acetylcysteine
Oral NAC 1200 mg x 2 doses
Placebo
Saline in tomato juice x 2 doses
03
Who it enrols
Adult patients with at least 2 nevi (>6 mm) not suspicious for melanoma, excluding those with severe asthma, recent extensive sunburn, or taking NAC/antioxidants.
04
Endpoints
Primary
UV-induced Oxidative Stress in Irradiated and Unirradiated Nevi
Secondary
Transcriptional Markers of UV-induced Oxidative Stress in Nevi
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