NCT05287724

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 19, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2024

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

1.5 years

First QC Date

March 7, 2022

Last Update Submit

March 5, 2024

Conditions

PruritusSkin Disorder

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

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.

Drug: N-acetyl cysteineDrug: 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.

Drug: N-acetyl cysteineDrug: Placebo

Interventions

N-acetyl cysteineDRUG

1,500 mg twice daily for seven days

N-acetyl Cysteine then PlaceboPlacebo then N-acetyl Cysteine
PlaceboDRUG

Placebo taken twice daily for seven days

N-acetyl Cysteine then PlaceboPlacebo then N-acetyl Cysteine

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and Females
  • All skin types (Fitzpatrick types I - VI)
  • Age 18 - 40
  • Able to comprehend procedures and risks

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location

MeSH Terms

Conditions

PruritusSkin Diseases

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Craig Rohan, MD

    Wright State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 18, 2022

Study Start

June 19, 2022

Primary Completion

January 4, 2024

Study Completion

January 4, 2024

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations

US(1)