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N-Acetyl Cysteine in Pathologic Skin Picking

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ClinicalTrials.gov Identifier: NCT01063348
Recruitment Status : Completed
First Posted : February 5, 2010
Results First Posted : October 31, 2016
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Jon Grant, University of Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Pathologic Skin Picking
Neurotic Excoriation
Psychogenic Excoriation
Dermatillomania
Interventions Drug: N-Acetyl Cysteine
Drug: Placebo
Enrollment 66
Recruitment Details  
Pre-assignment Details  
Arm/Group Title N-Acetyl Cysteine Placebo
Hide 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
Reason Not Completed
Lost to Follow-up             3             10
Arm/Group Title N-Acetyl Cysteine Placebo Total
Hide 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 Number of Baseline Participants 35 31 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 31 participants 66 participants
34.9  (11.6) 34.7  (10.5) 34.8  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 31 participants 66 participants
Female
33
  94.3%
25
  80.6%
58
  87.9%
Male
2
   5.7%
6
  19.4%
8
  12.1%
Any Psychiatric Comorbidity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 31 participants 66 participants
Yes 20 14 34
No 15 17 32
1.Primary Outcome
Title Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-Acetyl Cysteine Placebo
Hide 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.

Overall Number of Participants Analyzed 32 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-Acetyl Cysteine Placebo
Hide 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.

Overall Number of Participants Analyzed 32 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title N-Acetyl Cysteine Placebo
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
N-Acetyl Cysteine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/31 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
N-Acetyl Cysteine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   9/35 (25.71%)   1/31 (3.23%) 
Gastrointestinal disorders     
Nausea *  5/35 (14.29%)  1/31 (3.23%) 
Constipation *  2/35 (5.71%)  0/31 (0.00%) 
General disorders     
Dry Mouth *  1/35 (2.86%)  0/31 (0.00%) 
Dizziness *  1/35 (2.86%)  0/31 (0.00%) 
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Name/Title: Dr. Jon Grant
Organization: University of Chicago
Phone: 773-834-1325
Responsible Party: Jon Grant, University of Chicago
ClinicalTrials.gov Identifier: NCT01063348     History of Changes
Other Study ID Numbers: 2010PSPNAC
First Submitted: February 3, 2010
First Posted: February 5, 2010
Results First Submitted: April 19, 2016
Results First Posted: October 31, 2016
Last Update Posted: October 31, 2016