PruritusEarly Phase 1NCT05287724
Defining N-Acetyl Cysteine as a Treatment for Inhibiting Prurogenic Stimuli
A Early Phase 1 study testing N-acetyl cysteine in people with Pruritus and Skin Disorder, run by Wright State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pruritus, Skin Disorder
- What is being tested?
- N-acetyl cysteine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2022to 4 Jan 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and Females
- All skin types (Fitzpatrick types I - VI)
- Age 18 - 40
- Able to comprehend procedures and risks
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Studies Defining N-Acetyl Cysteine as a Treatment for Inhibiting Prurogenic Stimuli
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).
- Conditions
- Pruritus, Skin Disorder
- Being tested
- N-acetyl cysteine, Placebo
- Medical subject headings
- Pruritus, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl cysteineDrug
1,500 mg twice daily for seven days
PlaceboDrug
Placebo taken twice daily for seven days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: N-acetyl cysteine; Drug: 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. Receives: Drug: N-acetyl cysteine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start19 Jun 2022
- Primary completion4 Jan 2024
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wright State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Craig Rohan, MD, Principal investigator, Wright State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287724
- Sponsor's protocol ID
- 07126
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Studies Defining N-Acetyl Cysteine as a Treatment for Inhibiting Prurogenic Stimuli
- ClinicalTrials.gov ID
- NCT05287724
- Acronym / sponsor ID
- 07126
- Conditions
- Pruritus, Skin Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Study start
- 19 Jun 2022 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetyl Cysteine then Placebo | Experimental | Drug: N-acetyl cysteine, Drug: PlaceboSubjects 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 | Drug: N-acetyl cysteine, Drug: PlaceboSubjects 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and Females
- All skin types (Fitzpatrick types I - VI)
- Age 18 - 40
- Able to comprehend procedures and risks
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetyl cysteine1,500 mg twice daily for seven days | Drug | N-acetyl Cysteine then Placebo, Placebo then N-acetyl Cysteine |
| PlaceboPlacebo taken twice daily for seven days | Drug | N-acetyl Cysteine then Placebo, Placebo then N-acetyl Cysteine |
Primary outcome
Change in pain level from baseline with NAC.
Time frame: 7 days
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.
Time frame: 7 days
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.
Time frame: 7 days
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.
Time frame: 7 days
The change will be assessed from the Skin Itch Visual Analogue Scale (0 = no skin itch to 10 = severe skin itch).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Rohan, MD principal investigator
Wright State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing N-acetyl cysteine in people with Pruritus and Skin Disorder, run by Wright State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain level from baseline with NAC. (time frame: 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.