Pruritus, Skin Disorder
Conditions
Brief 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).
Interventions
DRUGN-acetyl cysteine
1,500 mg twice daily for seven days
DRUGPlacebo
Placebo taken twice daily for seven days
Sponsors
Wright State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Outcome results
None listed