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

Wright State University

Status and phase: Completed; Early Phase 1

Conditions: Skin Disorder; Pruritus

Treatments: Drug: Placebo; Drug: N-acetyl cysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT05287724

07126

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

N-acetyl Cysteine then Placebo

Experimental group

Description:

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.

Treatment:

Drug: N-acetyl cysteine

Drug: Placebo

Placebo then N-acetyl Cysteine

Experimental group

Description:

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.

Treatment:

Drug: N-acetyl cysteine

Drug: Placebo