Clinical trial · Interventional
Oral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo
A Phase II Placebo-controlled Intervention Trial of Oral N-acetylcysteine (NAC) for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patients at Risk for Melanoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| N-acetylcysteine | Drug | — | UNRESOLVED |
| Placebo arm | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patients receiving N-acetylcysteine
- description
- Patients receiving NAC (N-acetylcysteine)
- interventionNames
- Drug: N-acetylcysteine
- type
- PLACEBO_COMPARATOR
- label
- Placebo Group
- description
- Participants not receiving NAC (N-acetylcysteine)
- interventionNames
- Other: Placebo arm
Primary outcomes (1)
- measure
- UV-induced Oxidative Stress in Irradiated and Unirradiated Nevi
- timeFrame
- 3.5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have at least 2 nevi (each \>6 mm diameter) not clinically suspicious for melanoma that can be biopsied. * Must be able to receive informed consent and sign an approved consent form that conforms to federal and institutional guidelines. Exclusion Criteria: * The patient is a minor (\< 18 years old). * The patient cannot speak/understand English or Spanish. (NOTE: A Spanish consent form and certified interpreter can be made available if needed) * The patient is pregnant. (NOTE: All female patients who have not had a hysterectomy and are not post-menopausal (i.e. post-menopausal for 1 year and not of child-bearing potential) will have a urine pregnancy test.) * The patient is a prisoner, critically or mentally ill, or otherwise incapacitated or considered vulnerable. * The patient has history of allergic reaction to NAC. * The patient has history of severe asthma. * The patient has been taking NAC or any other oral antioxidant. * The patient has recent history (i.e., 3 months) of sunless tanning (tanning bed) or extensive sunburn.
References
Publications (0)
Data not yet available