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

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wright State University
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Males and Females

• All skin types (Fitzpatrick types I - VI)

• Age 18 - 40

• Able to comprehend procedures and risks

Exclusion Criteria:

• 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