Defining N-Acetyl Cysteine as a Treatment for Inhibiting Prurogenic Stimuli

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Pruritus, Skin Disorder

In brief

The objective of this double-blinded placebo-controlled cross-over study is to define the role of the over the counter agent, N-acetyl cysteine (NAC), in mitigating the development of pruritus (skin itching). The study is designed to have all subjects treated with a seven-day regimen of both NAC and placebo. NAC will be prescribed at a dose of 1,500 mg twice daily for seven days. Subjects will initially be randomly assigned (1:1) to either the NAC or placebo arm of the study, before crossing over to the opposite arm after completing a minimum of 30-day washout period. The study will encompass a period of approximately 11 weeks (about 2 and a half months).

Key facts

Study ID

NCT05287724

Run by

Wright State University

People needed

20

Starts

2022-06-19

Expected to finish

2024-01-04

Last updated by the study team

2024-03-06

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males and Females
• All skin types (Fitzpatrick types I - VI)
• Age 18 - 40
• Able to comprehend procedures and risks

You may not qualify if…

• Currently taking immunosuppressive or immunomodulating or psychotropic medications.
• This includes antihistamines and aspirin-like anti-inflammatory medications (NASIDs) for the past month.
• History of peripheral neuropathy, Charcot-Marie-Tooth, familial dysautonomia or heavy metal toxicity
• History of gastrointestinal abnormalities (including irritable bowel syndrome)
• History of inadequately controlled Diabetes Mellitus
• History of abnormal scarring
• History of skin infections within 6 weeks
• History of skin disease (atopic dermatitis, psoriasis, xerosis) or "sensitive skin"
• Pregnancy or nursing
• Other serious health issues, including liver or kidney disease

Where it is running

• Wright State Physicians — Fairborn, Ohio, United States

Full record on ClinicalTrials.gov

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