What side effects are associated with this type of intervention?

N-acetyl cysteine (NAC) is generally well-tolerated, but potential side effects include gastrointestinal disturbances such as nausea, vomiting, and diarrhea. Serlopitant, another treatment for pruritus, has been associated with mild toxicities. Nalbuphine ER, used for uremic pruritus, has shown serious adverse events in a small percentage of patients, including sleep disruption and other unspecified side effects. Overall, while these treatments can be effective, they may come with mild to moderate side effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

FDA-approved treatments for itching include topical corticosteroids and antihistamines, which reduce inflammation and block histamine receptors, respectively. Additionally, topical calcineurin inhibitors like tacrolimus and pimecrolimus are approved for atopic dermatitis and work by modulating the immune response to reduce inflammation and itching. These treatments share a common goal of reducing inflammation and immune response, similar to the proposed mechanism of N-acetyl cysteine (NAC), which is being studied for its potential to mitigate pruritus by reducing oxidative stress and inflammation.

What other types of research exist?

Promising alternatives to N-acetyl cysteine (NAC) for treating pruritus include: 1) 7,8,4'-Trihydroxyisoflavone (7,8,4'-THIF), which has shown efficacy in reducing atopic dermatitis-like symptoms and pruritus in mice; 2) Nedocromil sodium, which significantly reduces itch and flare in human skin; 3) Topical capsaicin, which has provided excellent symptomatic relief in cases of recalcitrant pruritus; and 4) Clemastine (Tavist) combined with fatty acid-containing supplements, which has shown synergistic effects in controlling pruritus in dogs. These treatments offer potential alternatives for patients seeking relief from itching.

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Mucolytic Agent

N-acetyl Cysteine for Itching

Q: What is the mechanism of action of this treatment?

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.

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

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

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 more

Side effects data

From 2022 Phase 2 trial • 44 Patients • NCT04005053

36%

Psychiatric

36%

Gastrointestinal

100%

80%

60%

40%

20%

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

~1240

Placebo

1995

Completed Phase 3

~2670

0 / 6Eligibility criteria met

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.