NCT05287724

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Wright State University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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).

Conditions

• Pruritus
• Skin Disorder

Interventions

Type	Name	Description
DRUG	N-acetyl cysteine	1,500 mg twice daily for seven days
DRUG	Placebo	Placebo taken twice daily for seven days

Timeline

• Start date: 2022-06-19
• Primary completion: 2024-01-04
• Completion: 2024-01-04
• First posted: 2022-03-18
• Last updated: 2024-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study