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NCT01612221 · ClinicalTrials.gov registry record · Phase 2
Oral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo
A Phase 2 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT01612221: Completed Phase 2 study, sponsored by University of Utah.
NCT01612221 is a Phase 2 study that has completed, run by University of Utah. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01612221, a Phase 2 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study 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.
Primary Outcome
Differences in the median percent nevus with 8-OG expression in UV-irradiated nevi compares with unirradiated nevi.
Interventions
- DRUG N-acetylcysteine
- OTHER Placebo arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2012-09 |
| Est. Completion | 2016-02 |
| Phase | Phase 2 |
What the finished NCT01612221 record still lists
NCT01612221 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which N-acetylcysteine is the first listed.
NCT01612221 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01612221 about?
NCT01612221 is a clinical study titled "Oral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo". 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)-in...
What is the current status of trial NCT01612221?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2012-09. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01612221?
The interventions under investigation include: N-acetylcysteine (DRUG), Placebo arm (OTHER).
Who is sponsoring clinical trial NCT01612221?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01612221's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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