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

NCT ID: NCT05287724

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-19
• Study Completion Date: 2024-01-04

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

N-acetyl Cysteine then Placebo

Subjects will be treated with N-acetyl cysteine twice daily for seven days. Subject will complete a minimum of 30-day washout period before crossing over to take the placebo.

Group Type: EXPERIMENTAL

N-acetyl cysteine

Intervention Type: DRUG

1,500 mg twice daily for seven days

Placebo

Intervention Type: DRUG

Placebo taken twice daily for seven days

Placebo then N-acetyl Cysteine

Subjects will be treated with placebo twice daily for seven days. Subject will complete a minimum of 30-day washout period before crossing over to take N-acetyl cysteine.

Group Type: EXPERIMENTAL

N-acetyl cysteine

Intervention Type: DRUG

1,500 mg twice daily for seven days

Placebo

Intervention Type: DRUG

Placebo taken twice daily for seven days

Interventions

N-acetyl cysteine

1,500 mg twice daily for seven days

Intervention Type: DRUG

Placebo

Placebo taken twice daily for seven days

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wright State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig Rohan, MD

Role: PRINCIPAL_INVESTIGATOR

Wright State University

Locations

Wright State Physicians

Fairborn, Ohio, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

07126

Identifier Type: -

Identifier Source: org_study_id