Trial Outcomes & Findings for Use of N-Acetylcysteine (NAC) in Fingernail Biting (NCT NCT01993849)

NCT ID: NCT01993849

Last Updated: 2018-10-03

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 23 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2018-10-03

Participant Flow

Participant milestones

Measure	N-Acetylcysteine Twice daily dosing for 8 weeks N-Acetylcysteine (NAC)	Placebo Twice daily dosing for 8 weeks Placebo
Overall Study STARTED	12	11
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of N-Acetylcysteine (NAC) in Fingernail Biting

Baseline characteristics by cohort

Measure	N-Acetylcysteine (NAC) n=12 Participants 1200 mg twice daily dosing for 8 weeks N-Acetylcysteine (NAC)	Placebo n=11 Participants Twice daily dosing for 8 weeks Placebo	Total n=23 Participants Total of all reporting groups
Age, Continuous	26.7 years STANDARD_DEVIATION 5.2 • n=5 Participants	27.4 years STANDARD_DEVIATION 4.7 • n=7 Participants	27.0 years STANDARD_DEVIATION 4.9 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The goal sample was to enroll at least 10 participants per arm/group within the specified recruitment period.

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.

Outcome measures

Measure	N-Acetylcysteine (NAC) n=12 Participants Oral N-acetylcysteine 1200 mg twice daily dosing for 8 weeks N-Acetylcysteine (NAC): This is the medication N-acetylcysteine (NAC)	Placebo n=11 Participants Oral placebo (matched in appearance to active treatment) twice daily dosing for 8 weeks Placebo: Placebo, designed to match in appearance to NAC
Number of Participants Enrolled Within One Year	12 Participants	11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: End of 8-week treatment

Length of nails, measured by caliper

Outcome measures

Measure	N-Acetylcysteine (NAC) n=12 Participants Oral N-acetylcysteine 1200 mg twice daily dosing for 8 weeks N-Acetylcysteine (NAC): This is the medication N-acetylcysteine (NAC)	Placebo n=11 Participants Oral placebo (matched in appearance to active treatment) twice daily dosing for 8 weeks Placebo: Placebo, designed to match in appearance to NAC
Measurement of Nail Length	10.12 millimeters Standard Deviation 2.43	10.73 millimeters Standard Deviation 3.40

Adverse Events

N-Acetylcysteine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	N-Acetylcysteine n=12 participants at risk 1200 mg twice daily dosing for 8 weeks N-Acetylcysteine (NAC)	Placebo n=11 participants at risk Twice daily dosing for 8 weeks Placebo
Nervous system disorders Headache	8.3% 1/12 • Number of events 1	0.00% 0/11

Additional Information

Kevin M. Gray, M.D.

Medical University of South Carolina

Phone: 843-792-6330

Email: graykm@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place