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

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

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).

Study Overview

• Status: Completed
• Conditions: Pruritus; Skin Disorder
• Intervention / Treatment: Drug: N-acetyl cysteine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Research Operations Manager; Phone Number: 937-245-7500; Email: elizabeth.cates@wrightstatephysicians.org
• Study Contact Backup: Name: Regulatory Specialist; Phone Number: 937-245-7500; Email: Christina.Knisely@wrightstatephysicians.org

Study Locations

• United States
  • Ohio
    • Fairborn, Ohio, United States, 45324
      • Wright State Physicians

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: N-acetyl cysteine; 1,500 mg twice daily for seven days; Drug: Placebo; Placebo taken twice daily for seven days
Experimental: 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.	Drug: N-acetyl cysteine; 1,500 mg twice daily for seven days; Drug: Placebo; Placebo taken twice daily for seven days

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wright State University
• Investigators: Principal Investigator: Craig Rohan, MD, Wright State University

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2022
• Primary Completion (Actual): January 4, 2024
• Study Completion (Actual): January 4, 2024

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations; Pruritus; Skin Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine
• Other Study ID Numbers: 07126

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes