Pathologic Skin PickingPhase 2NCT01063348
N-Acetyl Cysteine in Pathologic Skin Picking
A Phase 2 study testing N-Acetyl Cysteine in people with Pathologic Skin Picking and Neurotic Excoriation, run by University of Chicago at 1 site in United States.
Trial summary
The goal of the proposed study is to evaluate the comparative efficacy of N-acetyl cysteine to placebo in pathologic skin picking. Thirty subjects with pathologic skin picking will receive 12 weeks of double-blind treatment with N-acetyl cysteine or matching placebo. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Pathologic Skin Picking, Neurotic Excoriation, Psychogenic Excoriation
- What is being tested?
- N-Acetyl Cysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jul 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women age 18-65;
- Current diagnosis of pathologic skin picking as determined by criteria proposed by Arnold et al. (2001) for at least 6 months duration
Who cannot join
- Unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination;
- History of seizures;
- Myocardial infarction within 6 months;
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
- Need for medication other than NAC with possible psychotropic effects or unfavorable interactions with NAC;
- Clinically significant suicidality (score or 3 or 4 on item 3 of the Hamilton Depression Rating Scale);
Show all 13Show fewer
- Lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
- Current or recent (past 3 months) DSM-IV substance abuse or dependence;
- Illegal substance use within 2 weeks of study initiation;
- Initiation of pharmacotherapy, psychotherapy, or behavior therapy from a mental health professional within 3 months prior to study baseline for the treatment of pathologic skin picking;
- Previous treatment with N-acetyl cysteine;
- Treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline;
- Asthma (given possible worsening of asthma due to NAC)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled Study of N-Acetyl Cysteine in Pathologic Skin Picking
The goal of the proposed study is to evaluate the comparative efficacy of N-acetyl cysteine to placebo in pathologic skin picking. Thirty subjects with pathologic skin picking will receive 12 weeks of double-blind treatment with N-acetyl cysteine or matching placebo. The hypothesis to be tested is that N-acetyl cysteine will be more effective than placebo in patients with pathologic skin picking. The proposed study will provide needed data on the treatment of an often disabling disorder that currently lacks a clearly effective treatment.
Read the detailed description
Pathologic skin picking involves repetitive, ritualistic, or impulsive picking of otherwise normal skin leading to tissue damage, personal distress, and impaired functioning. Although skin picking has been described in the medical literature for over one-hundred years, it remains a poorly understood psychiatric issue and often goes undiagnosed and untreated.
Picking behavior does not by itself suggest a psychiatric disorder. Pathology exists in the focus, duration and extent of the behavior, as well as the reasons for picking, associated emotions, and resulting problems. Patients with PSP report thoughts of picking or impulses to pick that are irresistible, intrusive and/or senseless. These thoughts, impulses, or behaviors also cause marked distress for patients and significantly interfere with other activities. Unlike normal picking behavior, the pathologic form of skin picking is recurrent and usually results in noticeable skin damage.
Thirty subjects with pathologic skin picking will receive 12 weeks of double-blind treatment with N-acetyl cysteine or matching placebo. The hypothesis to be tested is that N-acetyl cysteine will be more effective than placebo in patients with pathologic skin picking. The proposed study will provide needed data on the treatment of an often disabling disorder that currently lacks a clearly effective treatment.
- Being tested
- N-Acetyl Cysteine, Placebo
- Keywords
- N-Acetyl Cysteine, Picking, Impulse Control Disorder, Obsessive Compulsive Disorder
- Medical subject headings
- Excoriation Disorder, Disruptive, Impulse Control, and Conduct Disorders, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Acetyl CysteineDrug
Also called NAC
Week 0 (Visit 1) - Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) - Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) - Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)
PlaceboDrug
Also called Sugar pill
Matching placebo capsules taken in same amount of pills as the active medication.
| Study group | Role | What they receive |
|---|---|---|
| N-Acetyl Cysteine | Active comparator | N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd) Receives: Drug: N-Acetyl Cysteine |
| Placebo | Placebo comparator | Matching placebo taken daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS)
The entire study for an individual subject will last 12 weeks. Every 3 weeks the subject will take the YBOCS for the duration of the 12 weeks. At each of these visits the outcome will be assessed.
The minimum score is 0 and the maximum score is 40, with a higher score being more severe skin picking. There are two sub-scales: one for urges (ranges from 0 to 20) and one for behaviors (ranges from 0 to 20). The total of the scores of each of the sub-scales is the total YBOCS score. That is what will be reported.
Measured: Once every three weeks during the 12 week study for each subject
Secondary outcomes (1)
Skin Picking Self Assessment Scale (SP-SAS)
The entire study for an individual subject will last 12 weeks. Every 3 weeks the subject will take the YBOCS for the duration of the 12 weeks. At each of these visits the outcome will be assessed.
The minimum score is 0 and the maximum score is 48 with higher scores meaning more severe skin picking. The total of all of the questions equals the total reported SP-SAS score.
Measured: Once every three weeks for the duration of the 12 week study for each subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startSep 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pathologic Skin PickingStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon E Grant, MD, JD, MPH, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063348
- Sponsor's protocol ID
- 2010PSPNAC
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2010
- Last updated
- 23 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Arnold LM, Auchenbach MB, McElroy SL. Psychogenic excoriation. Clinical features, proposed diagnostic criteria, epidemiology and approaches to treatment. CNS Drugs. 2001;15(5):351-9. doi: 10.2165/00023210-200115050-00002.
PubMed 11475941Grant JE, Odlaug BL. Update on pathological skin picking. Curr Psychiatry Rep. 2009 Aug;11(4):283-8. doi: 10.1007/s11920-009-0041-x.
PubMed 19635236Grant JE, Chesivoir E, Valle S, Ehsan D, Chamberlain SR. Double-Blind Placebo-Controlled Study of Memantine in Trichotillomania and Skin-Picking Disorder. Am J Psychiatry. 2023 May 1;180(5):348-356. doi: 10.1176/appi.ajp.20220737. Epub 2023 Feb 22.
PubMed 36856701Grant JE, Chamberlain SR, Redden SA, Leppink EW, Odlaug BL, Kim SW. N-Acetylcysteine in the Treatment of Excoriation Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 May 1;73(5):490-6. doi: 10.1001/jamapsychiatry.2016.0060.
PubMed 27007062
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study of N-Acetyl Cysteine in Pathologic Skin Picking
- ClinicalTrials.gov ID
- NCT01063348
- Acronym / sponsor ID
- 2010PSPNAC
- Keywords
- N-Acetyl Cysteine, Picking, Impulse Control Disorder, Obsessive Compulsive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 5 Feb 2010 (estimated)
- Results
- Posted 31 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the proposed study is to evaluate the comparative efficacy of N-acetyl cysteine to placebo in pathologic skin picking. Thirty subjects with pathologic skin picking will receive 12 weeks of double-blind treatment with N-acetyl cysteine or matching placebo. The hypothesis to be tested is that N-acetyl cysteine will be more effective than placebo in patients with pathologic skin picking. The proposed study will provide needed data on the treatment of an often disabling disorder that currently lacks a clearly effective treatment.
Detailed description
Pathologic skin picking involves repetitive, ritualistic, or impulsive picking of otherwise normal skin leading to tissue damage, personal distress, and impaired functioning. Although skin picking has been described in the medical literature for over one-hundred years, it remains a poorly understood psychiatric issue and often goes undiagnosed and untreated.
Picking behavior does not by itself suggest a psychiatric disorder. Pathology exists in the focus, duration and extent of the behavior, as well as the reasons for picking, associated emotions, and resulting problems. Patients with PSP report thoughts of picking or impulses to pick that are irresistible, intrusive and/or senseless. These thoughts, impulses, or behaviors also cause marked distress for patients and significantly interfere with other activities. Unlike normal picking behavior, the pathologic form of skin picking is recurrent and usually results in noticeable skin damage.
Thirty subjects with pathologic skin picking will receive 12 weeks of double-blind treatment with N-acetyl cysteine or matching placebo. The hypothesis to be tested is that N-acetyl cysteine will be more effective than placebo in patients with pathologic skin picking. The proposed study will provide needed data on the treatment of an often disabling disorder that currently lacks a clearly effective treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-Acetyl Cysteine | Active comparator | Drug: N-Acetyl CysteineN-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd) |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo taken daily |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men and women age 18-65;
- Current diagnosis of pathologic skin picking as determined by criteria proposed by Arnold et al. (2001) for at least 6 months duration
Key exclusion criteria (13 listed)
- Unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination;
- History of seizures;
- Myocardial infarction within 6 months;
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
- Need for medication other than NAC with possible psychotropic effects or unfavorable interactions with NAC;
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 CysteineAlso: NACWeek 0 (Visit 1) - Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) - Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) - Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm) | Drug | N-Acetyl Cysteine |
| PlaceboAlso: Sugar pillMatching placebo capsules taken in same amount of pills as the active medication. | Drug | Placebo |
Primary outcome
Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS)
Time frame: Once every three weeks during the 12 week study for each subject
The entire study for an individual subject will last 12 weeks. Every 3 weeks the subject will take the YBOCS for the duration of the 12 weeks. At each of these visits the outcome will be assessed. The minimum score is 0 and the maximum score is 40, with a higher score being more severe skin picking. There are two sub-scales: one for urges (ranges from 0 to 20) and one for behaviors (ranges from 0 to 20). The total of the scores of each of the sub-scales is the total YBOCS score. That is what will be reported.
1 secondary outcome
Skin Picking Self Assessment Scale (SP-SAS)
Time frame: Once every three weeks for the duration of the 12 week study for each subject
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11475941Arnold LM, Auchenbach MB, McElroy SL. Psychogenic excoriation. Clinical features, proposed diagnostic criteria, epidemiology and approaches to treatment. CNS Drugs. 2001;15(5):351-9. doi: 10.2165/00023210-200115050-00002.
- Background: PubMed 19635236Grant JE, Odlaug BL. Update on pathological skin picking. Curr Psychiatry Rep. 2009 Aug;11(4):283-8. doi: 10.1007/s11920-009-0041-x.
- Derived from this study: PubMed 36856701Grant JE, Chesivoir E, Valle S, Ehsan D, Chamberlain SR. Double-Blind Placebo-Controlled Study of Memantine in Trichotillomania and Skin-Picking Disorder. Am J Psychiatry. 2023 May 1;180(5):348-356. doi: 10.1176/appi.ajp.20220737. Epub 2023 Feb 22.
- Derived from this study: PubMed 27007062Grant JE, Chamberlain SR, Redden SA, Leppink EW, Odlaug BL, Kim SW. N-Acetylcysteine in the Treatment of Excoriation Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 May 1;73(5):490-6. doi: 10.1001/jamapsychiatry.2016.0060.
Related trials for Pathologic Skin Picking
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Outcomes of Cognitive Behavioral Therapy (CBT) Interventions Provided by Unlicensed Professionals
Obsessive Compulsive Disorder, Body Dysmorphic Disorder
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.
Jon E Grant, MD, JD, MPH principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-Acetyl Cysteine in people with Pathologic Skin Picking and Neurotic Excoriation, run by University of Chicago 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 2 inclusion and 13 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 23 Feb 2023. 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. Some participants in this study may receive a placebo. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS) (time frame: Once every three weeks during the 12 week study for each subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01063348, which also lists 4 linked publications.
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 23 Feb 2023.