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

NCT05287724 — Early Phase 1, Completed, 20 participants, Wright State University

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

Registry	NCT05287724
Status	Completed
Phase	Early Phase 1
Study type	Interventional; randomized, crossover, masking: double, treatment
Enrollment	20 (Actual)
Sponsor	Wright State University (Other)
Conditions	Pruritus, Skin Disorder
Interventions	N-acetyl cysteine, Placebo (Drug)
Dates	start 2022-06-19, primary completion 2024-01-04, completion 2024-01-04, first posted 2022-03-18, last updated 2024-03-06
Locations	1 site in United States

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
N-acetyl Cysteine then Placebo	Experimental	Drug: N-acetyl cysteine; Drug: Placebo	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.
Placebo then N-acetyl Cysteine	Experimental	Drug: N-acetyl cysteine; Drug: Placebo	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.

N-acetyl cysteine (Drug): 1,500 mg twice daily for seven days
Placebo (Drug): Placebo taken twice daily for seven days

+Outcome measures

Primary outcomes

Change in pain level from baseline with NAC. [7 days]: The change will be assessed from the Skin Pain Visual Analogue Scale (0 = no skin pain to 10 = severe skin pain).
Change in pain level from baseline with placebo. [7 days]: The change will be assessed from the Skin Pain Visual Analogue Scale (0 = no skin pain to 10 = severe skin pain).
Change in itch level from baseline with NAC. [7 days]: The change will be assessed from the Skin Itch Visual Analogue Scale (0 = no skin itch to 10 = severe skin itch).
Change in itch level from baseline with placebo. [7 days]: The change will be assessed from the Skin Itch Visual Analogue Scale (0 = no skin itch to 10 = severe skin itch).

+Eligibility

Sex: All, ages: 18 Years to 40 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Wright State Physicians	Fairborn, Ohio	United States

+Study documents

Informed Consent Form (PDF, 2022-05-02)

+Investigators

Craig Rohan, MD, Principal investigator, Wright State University