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

Study Overview
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Brief Summary
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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).

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

Conditions
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Pruritus, Skin Disorder

Intervention / Treatment
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* Drug: N-acetyl cysteine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-acetyl Cysteine then Placebo<br>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. | Drug: N-acetyl cysteine<br>* 1,500 mg twice daily for seven days<br>Drug: Placebo<br>* Placebo taken twice daily for seven days<br>|
| Experimental: Placebo then N-acetyl Cysteine<br>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. | Drug: N-acetyl cysteine<br>* 1,500 mg twice daily for seven days<br>Drug: Placebo<br>* Placebo taken twice daily for seven days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain level from baseline with NAC. | The change will be assessed from the Skin Pain Visual Analogue Scale (0 = no skin pain to 10 = severe skin pain). | 7 days | 
| Change in pain level from baseline with placebo. | The change will be assessed from the Skin Pain Visual Analogue Scale (0 = no skin pain to 10 = severe skin pain). | 7 days | 
| Change in itch level from baseline with NAC. | The change will be assessed from the Skin Itch Visual Analogue Scale (0 = no skin itch to 10 = severe skin itch). | 7 days | 
| Change in itch level from baseline with placebo. | The change will be assessed from the Skin Itch Visual Analogue Scale (0 = no skin itch to 10 = severe skin itch). | 7 days |