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

Primary Purpose

Pruritus, Skin Disorder

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

N-acetyl cysteine

Placebo

About this trial

This is an interventional treatment trial for Pruritus

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Wright State PhysiciansRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

N-acetyl Cysteine then Placebo

Placebo then N-acetyl Cysteine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

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).

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).

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT05287724

First Posted

March 7, 2022

Last Updated

February 22, 2023

Sponsor

Wright State University

1. Study Identification

Unique Protocol Identification Number

NCT05287724

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 19, 2022 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wright State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pruritus, Skin Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

N-acetyl Cysteine then Placebo

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo then N-acetyl Cysteine

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

N-acetyl cysteine

Intervention Description

1,500 mg twice daily for seven days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo taken twice daily for seven days

Primary Outcome Measure Information:

Title

Change in pain level from baseline with NAC.

Description

The change will be assessed from the Skin Pain Visual Analogue Scale (0 = no skin pain to 10 = severe skin pain).

Time Frame

7 days

Title

Change in pain level from baseline with placebo.

Description

The change will be assessed from the Skin Pain Visual Analogue Scale (0 = no skin pain to 10 = severe skin pain).

Time Frame

7 days

Title

Change in itch level from baseline with NAC.

Description

The change will be assessed from the Skin Itch Visual Analogue Scale (0 = no skin itch to 10 = severe skin itch).

Time Frame

7 days

Title

Change in itch level from baseline with placebo.

Description

The change will be assessed from the Skin Itch Visual Analogue Scale (0 = no skin itch to 10 = severe skin itch).

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Clinical Research Operations Manager

Phone

937-245-7500

elizabeth.cates@wrightstatephysicians.org

First Name & Middle Initial & Last Name or Official Title & Degree

Regulatory Specialist

Phone

937-245-7500

christina.knisely@wrightstatephysicians.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Craig Rohan, MD

Organizational Affiliation

Wright State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wright State Physicians

City

Fairborn

State/Province

Ohio

ZIP/Postal Code

45324

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Manager, Clinical Research Operations

Phone

937-245-7500

Elizabeth.Cates@wrightstatephysicians.org

First Name & Middle Initial & Last Name & Degree

Regulatory Specialist

Phone

937-245-7500

Christina.Knisely@wrightstatephysicians.org

First Name & Middle Initial & Last Name & Degree

Craig Rohan, MD

12. IPD Sharing Statement

Learn more about this trial

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

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