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Mucolytic Agent

N-acetyl Cysteine for Itching

Phase < 1
Waitlist Available
Led By Craig Rohan, MD
Research Sponsored by Wright State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to comprehend procedures and risks
Age 18 - 40
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights

Study Summary

This trial is testing whether the over-the-counter drug N-acetyl cysteine (NAC) can help reduce itching. The study will last for about 2 and a half months, and participants will take NAC or a placebo for a week before switching to the other option.

Who is the study for?
This trial is for people aged 18-40 with any skin type who can understand the study's procedures and risks. It's not for those with certain skin diseases, nerve disorders, uncontrolled diabetes, or recent use of immunosuppressants, antihistamines, NSAIDs or psychotropic drugs. Pregnant or nursing individuals and those with serious health issues like liver or kidney disease are also excluded.Check my eligibility
What is being tested?
The study tests N-Acetyl Cysteine (NAC), an over-the-counter supplement against a placebo to see if it reduces itching. Participants take either NAC at 1,500 mg twice daily or a placebo for seven days each, separated by a minimum of 30 days without treatment.See study design
What are the potential side effects?
While the side effects aren't detailed here, N-acetyl cysteine may commonly cause nausea, vomiting, diarrhea and constipation. Rarely it might lead to rashes or fever; however individual reactions can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I understand the procedures and risks involved.
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I am between 18 and 40 years old.
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I am either male or female.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in itch level from baseline with NAC.
Change in itch level from baseline with placebo.
Change in pain level from baseline with NAC.
+1 more

Side effects data

From 2022 Phase 2 trial • 44 Patients • NCT04005053
36%
Psychiatric
36%
Gastrointestinal
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low-Dose NAC
Placebo
High-Dose NAC

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo then N-acetyl CysteineExperimental Treatment2 Interventions
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 II: N-acetyl Cysteine then PlaceboExperimental Treatment2 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
N-acetyl cysteine
2016
Completed Phase 4
~990
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Wright State UniversityLead Sponsor
39 Previous Clinical Trials
54,784 Total Patients Enrolled
Craig Rohan, MDPrincipal InvestigatorWright State University
1 Previous Clinical Trials
24 Total Patients Enrolled

Media Library

N-acetyl cysteine (Mucolytic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05287724 — Phase < 1
Itching Research Study Groups: N-acetyl Cysteine then Placebo, Placebo then N-acetyl Cysteine
Itching Clinical Trial 2023: N-acetyl cysteine Highlights & Side Effects. Trial Name: NCT05287724 — Phase < 1
N-acetyl cysteine (Mucolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05287724 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteer participants are enrolled in this clinical trial?

"Affirmative. Data hosted on clinicaltrials.gov showcases that this medical trial, which was created on June 19th 2022 is conducting recruitment operations. The project necessitates the enrolment of 20 individuals from a single site."

Answered by AI

Are there any openings for prospective participants in this research project?

"The trial is currently seeking participants, as indicated by the data on clinicaltrials.gov. This study was initially posted in June of 2022 and has since been updated in September of that same year."

Answered by AI

Is there an age limit for patients involved in this research endeavor?

"This medical research trial is open to adults aged 18-40. For those under 18 and over 65, there are 16 and 61 alternative trials respectively."

Answered by AI

What are the eligibility requirements for participating in this clinical research?

"Eligibility requirements for this medical trial mandate that potential participants be between 18 and 40 years old, with the symptom of pruritus. The study's investigators are seeking 20 patients in total."

Answered by AI
~7 spots leftby Mar 2025