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

Pruritus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05287724
• Other study ID #: 07126
• Status: Completed
• Phase: Early Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Pruritus
• Skin Diseases
• Skin Disorder

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