Your session is about to expire
← Back to Search
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
Age 18 - 40
Be between 18 and 65 years old
Must not have
History of peripheral neuropathy, Charcot-Marie-Tooth, familial dysautonomia or heavy metal toxicity
History of inadequately controlled Diabetes Mellitus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
Summary
This trial tests if NAC, a common supplement, can help reduce skin itching. It targets people who experience itching and works by calming the body's irritation response. NAC has been shown to significantly alleviate acute and chronic itch in previous studies.
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.
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.
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 belowSelect...
I am between 18 and 40 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of nerve damage or specific genetic nerve disorders.
Select...
My diabetes is not well-controlled.
Select...
I have been taking medications that affect my immune system or mood, including antihistamines or NSAIDs, in the last month.
Select...
I have a history of stomach or bowel problems.
Select...
I do not have serious liver or kidney disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSide effects data
From 2022 Phase 2 trial • 44 Patients • NCT0400505336%
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
2023
Completed Phase 4
~1130
Placebo
1995
Completed Phase 3
~2670
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for itching work through various mechanisms to provide relief. N-acetyl cysteine (NAC) is an antioxidant and mucolytic agent that may reduce oxidative stress and inflammation, potentially alleviating pruritus.
Topical capsaicin desensitizes sensory neurons, reducing the sensation of itch. Low-dose naltrexone modulates the immune response and reduces inflammation.
These treatments are crucial for itching patients as they offer multiple pathways to target the underlying causes of itch, improving the chances of effective symptom management.
Prurigo excoriée treated with low dose naltrexone.
Prurigo excoriée treated with low dose naltrexone.
Find a Location
Who is running the clinical trial?
Wright State UniversityLead Sponsor
45 Previous Clinical Trials
55,088 Total Patients Enrolled
Craig Rohan, MDPrincipal InvestigatorWright State University
1 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am either male or female.I have a history of skin conditions like eczema, psoriasis, or very dry skin.I have a history of nerve damage or specific genetic nerve disorders.People with any skin type can participate.I understand the procedures and risks involved.My diabetes is not well-controlled.I have not had a skin infection in the last 6 weeks.I have been taking medications that affect my immune system or mood, including antihistamines or NSAIDs, in the last month.I am between 18 and 40 years old.You have had unusual scarring in the past.I have a history of stomach or bowel problems.I do not have serious liver or kidney disease.
Research Study Groups:
This trial has the following groups:- Group 1: N-acetyl Cysteine then Placebo
- Group 2: Placebo then N-acetyl Cysteine
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger