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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if N-acetyl cysteine (NAC), a common over-the-counter supplement, can reduce skin itching. Participants will take NAC and a placebo, each for a week with a break in between, to compare their effects. Individuals experiencing itching who are not currently taking certain medications or have specific medical conditions might be suitable candidates. The trial will last about 11 weeks. As an Early Phase 1 trial, this research focuses on understanding how NAC works in people, offering participants a chance to contribute to groundbreaking insights.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that N-acetyl cysteine (NAC) is generally safe, with most people tolerating it well and serious side effects being rare. Studies indicate a low risk of harmful effects, especially when taken in normal amounts. Some individuals might experience minor side effects like nausea or a skin rash. There is also a small chance of increased bleeding, so individuals with bleeding disorders should exercise caution.

In past studies, NAC was used safely for various purposes, including reducing itching. While serious side effects are uncommon, discussing any concerns with a doctor before joining a trial is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for itching?

N-acetyl cysteine is unique because it offers a potential new way to address itching, which is often treated with antihistamines or corticosteroids. Unlike these standard treatments, N-acetyl cysteine is an antioxidant that targets oxidative stress, a different underlying cause of itching. Researchers are excited about its potential to provide relief, especially since it may work quickly and with fewer side effects than current options.

What evidence suggests that N-acetyl cysteine might be an effective treatment for itching?

Research has shown that N-acetyl cysteine (NAC), which participants in this trial may receive, might help with itching. Studies have found that NAC can lower stress and swelling in the body, potentially leading to skin problems. This suggests it might help reduce itching. NAC is also considered safe and easy to tolerate for various skin issues. While more research is needed specifically on itching, these findings suggest it could be useful for relieving itchiness. ^{1 5 6 7 8}

Who Is on the Research Team?

Craig Rohan, MD

Principal Investigator

Wright State University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8234027/

N-Acetylcysteine (NAC): Impacts on Human Health - PMC Animal studies have shown that NAC exerts a potent protective effect against oxidative stress and inflammation under different conditions, including improvement ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6561714/

The Potential Uses of N-acetylcysteine in Dermatology N-acetylcysteine could potentially serve as a safe, tolerable, and effective therapeutic option for a variety of dermatologic conditions.

3. journals.lww.com journals.lww.com/itch/fulltext/2023/01010/role_of_antioxidants_in_itch_treatment__lessons.5.aspx

Role of antioxidants in itch treatment: lessons learned... Other studies have demonstrated an increase in oxidative stress and a decrease in antioxidant levels in children with atopic dermatitis40,41.

4. withpower.com withpower.com/trial/early-phase-1-pruritus-3-2022-d6a85

N-acetyl Cysteine for Itching · Info for Participants 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 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0149763415001190

Clinical trials of N-acetylcysteine in psychiatry and neurology In this systematic review we find favorable evidence for the use of NAC in several psychiatric and neurological disorders.

6. webmd.com webmd.com/vitamins/ai/ingredientmono-1018/n-acetyl-cysteine-nac

N-Acetyl Cysteine (Nac) – Uses, Side Effects, and More When inhaled: N-acetyl cysteine is likely safe for most adults, when used as a prescription medication. It can cause swelling in the mouth, runny nose, ...

7. hhs.texas.gov hhs.texas.gov/sites/default/files/documents/acetylcysteine-nac-monograph.pdf

N-acetylcysteine (NAC) monograph Interactions with medical conditions: Bleeding disorders: N-acetyl cysteine might increase the risk of bleeding; therefore, use with caution in ...

8. drugs.com drugs.com/sfx/nac-side-effects.html

NAC Side Effects: Common, Severe, Long Term Tell your doctor right away if you have difficulty with breathing or swallowing, fever, hives, itching skin, rash, nausea, reddening of the skin ...