N-Acetyl Cysteine in Pathologic Skin Picking

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT01063348
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 2
• Duration (Months): 33.9
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Pathologic Skin Picking; Neurotic Excoriation; Psychogenic Excoriation; Dermatillomania	Drug: N-Acetyl Cysteine; Drug: Placebo	Phase 2

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

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Placebo-Controlled Study of N-Acetyl Cysteine in Pathologic Skin Picking
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: N-Acetyl Cysteine N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)	Drug: N-Acetyl Cysteine; 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); Other Names: NAC
Placebo Comparator: Placebo Matching placebo taken daily	Drug: Placebo; Matching placebo capsules taken in same amount of pills as the active medication.; Other Names: Sugar pill

Outcome Measures

Primary Outcome Measures

1. Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS) [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.

Secondary Outcome Measures

1. Skin Picking Self Assessment Scale (SP-SAS) [Once every three weeks for the duration of 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 48 with higher scores meaning more severe skin picking. The total of all of the questions equals the total reported SP-SAS score.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Men and women age 18-65;

2. Current diagnosis of pathologic skin picking as determined by criteria proposed by Arnold et al. (2001) for at least 6 months duration

Exclusion Criteria:

1. Unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination;

2. History of seizures;

3. Myocardial infarction within 6 months;

4. Current pregnancy or lactation, or inadequate contraception in women of childbearing potential;

5. Need for medication other than NAC with possible psychotropic effects or unfavorable interactions with NAC;

6. Clinically significant suicidality (score or 3 or 4 on item 3 of the Hamilton Depression Rating Scale);

7. Lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;

8. Current or recent (past 3 months) DSM-IV substance abuse or dependence;

9. Illegal substance use within 2 weeks of study initiation;

10. 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;

11. Previous treatment with N-acetyl cysteine;

12. 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;

13. Asthma (given possible worsening of asthma due to NAC)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago

Investigators

• Principal Investigator: Jon E Grant, MD, JD, MPH, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

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. Review.
• Grant JE, Odlaug BL. Update on pathological skin picking. Curr Psychiatry Rep. 2009 Aug;11(4):283-8. Review.

• Responsible Party: Jon Grant, Professor of Psychiatry, University of Chicago
• ClinicalTrials.gov Identifier: NCT01063348
• Other Study ID Numbers: 2010PSPNAC
• First Posted: Feb 5, 2010
• Last Update Posted: Oct 31, 2016
• Last Verified: Sep 1, 2016

• Keywords provided by Jon Grant, Professor of Psychiatry, University of Chicago: N-Acetyl Cysteine; Picking; Impulse Control Disorder; Obsessive Compulsive Disorder
• Additional relevant MeSH terms: Acetylcysteine; N-monoacetylcystine

Study Results

Participant Flow

Arm/Group Title	N-Acetyl Cysteine	Placebo
Arm/Group Description	N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd) N-Acetyl Cysteine: 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)	Matching placebo taken daily Placebo: Matching placebo capsules taken in same amount of pills as the active medication.
Period Title: Overall Study
STARTED	35	31
COMPLETED	32	21
NOT COMPLETED	3	10

Baseline Characteristics

Arm/Group Title	N-Acetyl Cysteine	Placebo	Total
Arm/Group Description	N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd) N-Acetyl Cysteine: 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)	Matching placebo taken daily Placebo: Matching placebo capsules taken in same amount of pills as the active medication.	Total of all reporting groups
Overall Participants	35	31	66
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.9 (11.6)	34.7 (10.5)	34.8 (11.0)
Sex: Female, Male (Count of Participants)
Female	33 94.3%	25 80.6%	58 87.9%
Male	2 5.7%	6 19.4%	8 12.1%
Any Psychiatric Comorbidity (participants) [Number]
Yes	20 57.1%	14 45.2%	34 51.5%
No	15 42.9%	17 54.8%	32 48.5%

Outcome Measures

1. Primary Outcome

Title	Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS)
Description	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.
Time Frame	Once every three weeks during the 12 week study for each subject

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	N-Acetyl Cysteine	Placebo
Arm/Group Description	N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd) N-Acetyl Cysteine: 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)	Matching placebo taken daily Placebo: Matching placebo capsules taken in same amount of pills as the active medication.
Measure Participants	32	21
Baseline	18.8 (5.3)	17.6 (4.8)
Week 3	16.1 (5.9)	17.3 (5.4)
Week 6	13.9 (6.3)	16.3 (6.9)
Week 9	12.4 (5.8)	15.0 (7.4)
Week 12	11.5 (5.4)	14.1 (7.5)

2. Secondary Outcome

Title	Skin Picking Self Assessment Scale (SP-SAS)
Description	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.
Time Frame	Once every three weeks for the duration of the 12 week study for each subject

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	N-Acetyl Cysteine	Placebo
Arm/Group Description	N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd) N-Acetyl Cysteine: 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)	Matching placebo taken daily Placebo: Matching placebo capsules taken in same amount of pills as the active medication.
Measure Participants	32	21
Baseline	28.6 (6.2)	28.6 (7.0)
Week 3	24.8 (7.2)	25.5 (6.2)
Week 6	21.9 (8.0)	25.0 (8.8)
Week 9	21.5 (10.3)	24.2 (8.5)
Week 12	19.4 (8.7)	24.5 (9.0)

Adverse Events

Arm/Group Title	N-Acetyl Cysteine		Placebo
Arm/Group Description	N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd) N-Acetyl Cysteine: 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)		Matching placebo taken daily Placebo: Matching placebo capsules taken in same amount of pills as the active medication.
All Cause Mortality
	N-Acetyl Cysteine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	N-Acetyl Cysteine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	N-Acetyl Cysteine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/35 (25.7%)		1/31 (3.2%)
Gastrointestinal disorders
Nausea	5/35 (14.3%)		1/31 (3.2%)
Constipation	2/35 (5.7%)		0/31 (0%)
General disorders
Dry Mouth	1/35 (2.9%)		0/31 (0%)
Dizziness	1/35 (2.9%)		0/31 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.