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NCT Number: NCT05287724

Defining N-Acetyl Cysteine as a Treatment for Inhibiting Prurogenic Stimuli

The objective of this double-blinded placebo-controlled cross-over study is to define the role of the over the counter agent, N-acetyl cysteine (NAC), in mitigating the development of pruritus (skin itching). The study is designed to have all subjects treated with a seven-day regimen of both NAC and placebo. NAC will be prescribed at a dose of 1,500 mg twice daily for seven days. Subjects will initially be randomly assigned (1:1) to either the NAC or placebo arm of the study, before crossing over to the opposite arm after completing a minimum of 30-day washout period. The study will encompass a period of approximately 11 weeks (about 2 and a half months).

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Key information

Conditions

Pruritus Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Disorder Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Wright State Physicians

Fairborn, Ohio, 45324, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and Females
  • All skin types (Fitzpatrick types I - VI)
  • Age 18 - 40
  • Able to comprehend procedures and risks

Exclusion criteria

  • Currently taking immunosuppressive or immunomodulating or psychotropic medications.

This includes antihistamines and aspirin-like anti-inflammatory medications (NASIDs) for the past month.

  • History of peripheral neuropathy, Charcot-Marie-Tooth, familial dysautonomia or heavy metal toxicity
  • History of gastrointestinal abnormalities (including irritable bowel syndrome)
  • History of inadequately controlled Diabetes Mellitus
  • History of abnormal scarring
  • History of skin infections within 6 weeks
  • History of skin disease (atopic dermatitis, psoriasis, xerosis) or "sensitive skin"
  • Pregnancy or nursing
  • Other serious health issues, including liver or kidney disease

Treatment and study plan

N-acetyl cysteine

Drug

1,500 mg twice daily for seven days

Placebo

Drug

Placebo taken twice daily for seven days

Primary outcomes

  1. Change in pain level from baseline with NAC.

    Time frame: 7 days

    The change will be assessed from the Skin Pain Visual Analogue Scale (0 = no skin pain to 10 = severe skin pain).

  2. Change in pain level from baseline with placebo.

    Time frame: 7 days

    The change will be assessed from the Skin Pain Visual Analogue Scale (0 = no skin pain to 10 = severe skin pain).

  3. Change in itch level from baseline with NAC.

    Time frame: 7 days

    The change will be assessed from the Skin Itch Visual Analogue Scale (0 = no skin itch to 10 = severe skin itch).

  4. Change in itch level from baseline with placebo.

    Time frame: 7 days

    The change will be assessed from the Skin Itch Visual Analogue Scale (0 = no skin itch to 10 = severe skin itch).

Sponsors and collaborators

Lead sponsor

Wright State University

Other

Registry information

Official study title

Pilot Studies Defining N-Acetyl Cysteine as a Treatment for Inhibiting Prurogenic Stimuli

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 18, 2022
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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