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

Early Phase 1

Completed

• Conditions: Skin Disorder; Pruritus
• Interventions: Drug: N-acetyl cysteine; Drug: Placebo

• Registration Number: NCT05287724
• Lead Sponsor: Wright State University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-07
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-18
• Study Start: 2022-06-19
• Primary Completion: 2024-01-04
• Study Completion: 2024-01-04
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
N-acetyl Cysteine then Placebo	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.
N-acetyl Cysteine then Placebo	N-acetyl cysteine	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.
Placebo then N-acetyl Cysteine	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.
Placebo then N-acetyl Cysteine	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Change in pain level from baseline with NAC.	7 days	The change will be assessed from the Skin Pain Visual Analogue Scale (0 = no skin pain to 10 = severe skin pain).
Change in itch level from baseline with NAC.	7 days	The change will be assessed from the Skin Itch Visual Analogue Scale (0 = no skin itch to 10 = severe skin itch).
Change in itch level from baseline with placebo.	7 days	The change will be assessed from the Skin Itch Visual Analogue Scale (0 = no skin itch to 10 = severe skin itch).
Change in pain level from baseline with placebo.	7 days	The change will be assessed from the Skin Pain Visual Analogue Scale (0 = no skin pain to 10 = severe skin pain).

Trial Locations

Locations (1)

Wright State Physicians; 🇺🇸 Fairborn, Ohio, United States