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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05287724
Other study ID # 07126
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date June 19, 2022
Est. completion date January 4, 2024

Study information

Verified date March 2024
Source Wright State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 4, 2024
Est. primary completion date January 4, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Wright State Physicians Fairborn Ohio

Sponsors (1)

Lead Sponsor Collaborator
Wright State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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