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Use of N-Acetylcysteine (NAC) in Fingernail Biting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01993849
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : October 3, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Kevin Gray, MD, Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Onychophagia
Interventions Drug: N-Acetylcysteine (NAC)
Other: Placebo
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title N-Acetylcysteine Placebo
Hide Arm/Group Description

Twice daily dosing for 8 weeks

N-Acetylcysteine (NAC)

Twice daily dosing for 8 weeks

Placebo

Period Title: Overall Study
Started 12 11
Completed 9 9
Not Completed 3 2
Arm/Group Title N-Acetylcysteine (NAC) Placebo Total
Hide Arm/Group Description

1200 mg twice daily dosing for 8 weeks

N-Acetylcysteine (NAC)

Twice daily dosing for 8 weeks

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 12 11 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 11 participants 23 participants
26.7  (5.2) 27.4  (4.7) 27.0  (4.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 23 participants
Female
9
  75.0%
8
  72.7%
17
  73.9%
Male
3
  25.0%
3
  27.3%
6
  26.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 23 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   8.3%
0
   0.0%
1
   4.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  25.0%
2
  18.2%
5
  21.7%
White
8
  66.7%
9
  81.8%
17
  73.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants Enrolled Within One Year
Hide Description Ability to enroll the goal sample within one year; we are interested in the feasibility of sufficient enrollment and data collection within a given period of time.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The goal sample was to enroll at least 10 participants per arm/group within the specified recruitment period.
Arm/Group Title N-Acetylcysteine (NAC) Placebo
Hide Arm/Group Description:

Oral N-acetylcysteine 1200 mg twice daily dosing for 8 weeks

N-Acetylcysteine (NAC): This is the medication N-acetylcysteine (NAC)

Oral placebo (matched in appearance to active treatment) twice daily dosing for 8 weeks

Placebo: Placebo, designed to match in appearance to NAC

Overall Number of Participants Analyzed 12 11
Measure Type: Count of Participants
Unit of Measure: Participants
12
 100.0%
11
 100.0%
2.Other Pre-specified Outcome
Title Measurement of Nail Length
Hide Description Length of nails, measured by caliper
Time Frame End of 8-week treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-Acetylcysteine Placebo
Hide Arm/Group Description:

1200 mg twice daily dosing for 8 weeks

N-Acetylcysteine (NAC)

Twice daily dosing for 8 weeks

Placebo

Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: millimeters
10.12  (2.43) 10.73  (3.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N-Acetylcysteine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments The p-value was calculated, and is not attempting to indicate the threshold for statistical significance.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
-3.81 to 2.59
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title N-Acetylcysteine Placebo
Hide Arm/Group Description

1200 mg twice daily dosing for 8 weeks

N-Acetylcysteine (NAC)

Twice daily dosing for 8 weeks

Placebo

All-Cause Mortality
N-Acetylcysteine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
N-Acetylcysteine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/11 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
N-Acetylcysteine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/12 (8.33%)      0/11 (0.00%)    
Nervous system disorders     
Headache   1/12 (8.33%)  1 0/11 (0.00%)  0
Indicates events were collected by 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
Layout table for Results Point of Contact information
Name/Title: Kevin M. Gray, M.D.
Organization: Medical University of South Carolina
Phone: 843-792-6330
EMail: graykm@musc.edu
Layout table for additonal information
Responsible Party: Kevin Gray, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01993849    
Other Study ID Numbers: Pro00028506
First Submitted: September 24, 2013
First Posted: November 25, 2013
Results First Submitted: April 24, 2018
Results First Posted: October 3, 2018
Last Update Posted: October 3, 2018