Trial Outcomes & Findings for Oral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo (NCT NCT01612221)

NCT ID: NCT01612221

Last Updated: 2017-07-31

Results Overview

Differences in the median percent nevus with 8-OG expression in UV-irradiated nevi compares with unirradiated nevi.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 100 participants
• Primary outcome timeframe: 3.5 years
• Results posted on: 2017-07-31

Participant Flow

Participant milestones

Measure	Patients Receiving N-acetylcysteine Patients receiving NAC (N-acetylcysteine) N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses	Placebo Group Participants not receiving NAC (N-acetylcysteine) Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose. Then repeated 24 hours later.
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo

Baseline characteristics by cohort

Measure	Patients Receiving N-acetylcysteine n=50 Participants Patients receiving NAC (N-acetylcysteine) N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses	Placebo Group n=50 Participants Participants not receiving NAC (N-acetylcysteine) Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose. Then repeated 24 hours later.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=5 Participants	46 Participants n=7 Participants	93 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	17 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	33 Participants n=7 Participants	61 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants	50 Participants n=7 Participants	100 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
Region of Enrollment United States	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3.5 years

Population: One subject with low-risk MC1R randomized to drug was excluded from both analyses because the lesions removed were seborrheic keratoses and not nevi, and 2 subjects (one high-risk MC1R randomized to drug and one low-risk MC1R randomized to placebo) were excluded from analysis of 8-OG because there was insufficient tissue.

Differences in the median percent nevus with 8-OG expression in UV-irradiated nevi compares with unirradiated nevi.

Outcome measures

Measure	Patients Receiving N-acetylcysteine n=48 Participants Patients receiving NAC (N-acetylcysteine) N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses	Placebo Group n=49 Participants Participants not receiving NAC (N-acetylcysteine) Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose. Then repeated 24 hours later.
UV-induced Oxidative Stress in Irradiated and Unirradiated Nevi UV Irradiated	94.6 percentage of 8-OG expression in nevi Standard Deviation 12.3	96.2 percentage of 8-OG expression in nevi Standard Deviation 7.5
UV-induced Oxidative Stress in Irradiated and Unirradiated Nevi Unirradiated	33.6 percentage of 8-OG expression in nevi Standard Deviation 25.1	33.1 percentage of 8-OG expression in nevi Standard Deviation 24.2

SECONDARY outcome

Timeframe: 3.5 years

Population: One subject with low-risk MC1R randomized to drug was excluded because the lesions removed were seborrheic keratoses and not nevi.

Biomarkers susceptible to UV-induced damage protected by NAC (N-acetylcysteine) in irradiated and unirradiated nevi

Outcome measures

Measure	Patients Receiving N-acetylcysteine n=49 Participants Patients receiving NAC (N-acetylcysteine) N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses	Placebo Group n=50 Participants Participants not receiving NAC (N-acetylcysteine) Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose. Then repeated 24 hours later.
Transcriptional Markers of UV-induced Oxidative Stress in Nevi GCLM Biomarker	8.99 markers of UV-induced oxidative stress Standard Deviation .83	9.14 markers of UV-induced oxidative stress Standard Deviation .75
Transcriptional Markers of UV-induced Oxidative Stress in Nevi SLC1A4 Biomarker	9.29 markers of UV-induced oxidative stress Standard Deviation .87	9.40 markers of UV-induced oxidative stress Standard Deviation 1.06
Transcriptional Markers of UV-induced Oxidative Stress in Nevi SLC7A11 Biomarker	8.73 markers of UV-induced oxidative stress Standard Deviation 1.13	9.03 markers of UV-induced oxidative stress Standard Deviation .95

Adverse Events

Patients Receiving N-acetylcysteine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kimberlee Taylor

Huntsman Cancer Institute

Phone: 801-213-5673

Email: Kimberlee.Taylor@hci.utah.edu

Results disclosure agreements

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