N-acetyl Cysteine for Itching

Overseen By Regulatory Specialist

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Wright State University

Must not be taking: Immunosuppressants, Psychotropics, Antihistamines, NSAIDs

Disqualifiers: Peripheral neuropathy, Diabetes, Skin disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 11 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are currently taking immunosuppressive, immunomodulating, psychotropic medications, antihistamines, or NSAIDs (like aspirin), you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the drug N-acetyl cysteine for itching?

N-acetyl cysteine is known for its mucolytic properties, which help break down mucus in respiratory conditions, and it is also used as an antidote for acetaminophen poisoning. However, there is no direct evidence from the provided research articles supporting its effectiveness specifically for treating itching. ^{1 2 3 4 5}

Is N-acetyl cysteine generally safe for humans?

N-acetyl cysteine (NAC) can cause histamine release, which might lead to adverse reactions if not properly neutralized. High concentrations of NAC have been shown to affect the cells in the trachea, and there have been reports of respiratory issues in children, leading to its withdrawal for infants in some countries. However, NAC is also known for its protective effects against kidney injury, indicating it has some safety benefits when used appropriately. ^{1 4 5 6 7}

How does the drug N-acetyl cysteine differ from other treatments for itching?

N-acetyl cysteine is unique because it has mucolytic properties, meaning it can break down mucus, and it also releases histamine, which might affect itching. Unlike typical antihistamines used for itching, it has a different mechanism of action and is also used for other conditions like chronic bronchitis and acetaminophen poisoning. ^{1 3 4 5 8}

Research Team

Craig Rohan, MD

Principal Investigator

Wright State University

Eligibility Criteria

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.

Inclusion Criteria

I am either male or female.

People with any skin type can participate.

I understand the procedures and risks involved.

Exclusion Criteria

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.

My diabetes is not well-controlled.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a seven-day regimen of either NAC or placebo, followed by a 30-day washout period, then crossover to the opposite treatment for another seven days

11 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• N-acetyl cysteine
• Placebo

Trial Overview 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.

Participant Groups

Group I: Placebo then N-acetyl Cysteine Experimental Treatment 2 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 Placebo Experimental Treatment 2 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.

N-acetyl cysteine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Acetylcysteine for:

• Acetaminophen overdose
• Chronic bronchitis
• Chronic obstructive pulmonary disease (COPD)
• Cystic fibrosis

Approved in European Union as Acetylcysteine for:

• Acetaminophen overdose
• Chronic bronchitis
• Chronic obstructive pulmonary disease (COPD)
• Cystic fibrosis

Approved in Canada as Acetylcysteine for:

• Acetaminophen overdose
• Chronic bronchitis
• Chronic obstructive pulmonary disease (COPD)
• Cystic fibrosis

Who Is Running the Clinical Trial?

Wright State University

Lead Sponsor

Trials

47

Recruited

55,300+

Findings from Research

N-Acetylcysteine is effective as a mucolytic agent for chronic bronchitis and as an antidote for paracetamol poisoning, with peak plasma concentrations achieved within 1 to 2 hours after oral doses of 200 to 400 mg.

While it has significant therapeutic benefits, common side effects include nausea, vomiting, and diarrhea, and it may interact with other drugs, particularly paracetamol and certain anticancer agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical pharmacokinetics of N-acetylcysteine. Holdiness, MR.[2022]

Contrast-induced acute kidney injury (CI-AKI) is a significant cause of hospital-acquired renal failure, affecting about 10% of cases and leading to longer hospital stays and worse patient outcomes.

N-acetylcysteine (NAC) is a promising treatment due to its antioxidant properties, which may help prevent CI-AKI by scavenging harmful free radicals, although the study will further explore its effectiveness through experimental and clinical data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nephrotoxicity of contrast media and protective effects of acetylcysteine. Briguori, C., Quintavalle, C., De Micco, F., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Histamine secretion induced by N-acetyl cysteine. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Acetylcysteine and carbocysteine for acute upper and lower respiratory tract infections in paediatric patients without chronic broncho-pulmonary disease. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical pharmacokinetics of N-acetylcysteine. [2022]

4. Denmark pubmed.ncbi.nlm.nih.gov

Acetylcysteine and its derivatives: functional and morphological effects on tracheal mucosa in vitro. [2013]

5. France pubmed.ncbi.nlm.nih.gov

[Acetyl-cysteine in colonic mucography (author's transl)]. [2016]

6. Germany pubmed.ncbi.nlm.nih.gov

Nephrotoxicity of contrast media and protective effects of acetylcysteine. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Respiratory paradoxical adverse drug reactions associated with acetylcysteine and carbocysteine systemic use in paediatric patients: a national survey. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Mucolytic and Antioxidant Effects of Intranasal Acetylcysteine Use on Acute Rhinosinusitis in Rats with an Acute Rhinosinusitis Model. [2022]