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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-acetyl Cysteine then Placebo | Experimental | 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetyl cysteine | Drug | 1,500 mg twice daily for seven days |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
This includes antihistamines and aspirin-like anti-inflammatory medications (NASIDs) for the past month.
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| Name | Affiliation | Role |
|---|---|---|
| Craig Rohan, MD | Wright State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wright State Physicians | Fairborn | Ohio | 45324 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 2, 2022 | Feb 20, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo taken twice daily for seven days |
|
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |