Trial Outcomes & Findings for Prevention of Alcohol Intolerance (NCT NCT01845220)

Last Updated: 2017-09-29

Results Overview

For three days in a row, volunteers will receive skin treatments with broccoli sprout extract. On day four, their skin will be measured for a baseline skin color reading. Immediately following this reading, the treated areas of the skin will be challenged with 70 percent alcohol and the redness of the skin will again be measured every 30 minutes for the following two hours for skin color changes. The values were collected every 30 minutes after the alcohol skin challenge for 2 hours and were averaged. Mean and 95% Confidence Interval are reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

mean up to 2 hours

Results posted on

2017-09-29

Participant Flow

Unit of analysis: skin area

Participant milestones

Participant milestones
Measure	Broccoli Sprout Extract Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions. Broccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge	Placebo Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions. Placebo: 80% acetone
Overall Study STARTED	30 30	30 30
Overall Study COMPLETED	30 30	30 30
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevention of Alcohol Intolerance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=30 Participants Total number of subjects is 30. Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions. Thus, 60 skin areas will be randomized. Broccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge Placebo Comparator.
Age, Continuous	34 years n=93 Participants
Sex: Female, Male Female	16 Participants n=93 Participants
Sex: Female, Male Male	14 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	30 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	30 participants n=93 Participants

PRIMARY outcome

Timeframe: mean up to 2 hours

Population: Since experimental conditions were refined part way through the series and only the last 19 individuals' data was deemed suitable for analysis.

Outcome measures

Outcome measures
Measure	Broccoli Sprout Extract n=19 Participants Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions. Broccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge	Placebo n=19 Participants Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions. Placebo: 80% acetone
Mean Area of Skin Erythema (Skin Redness)	3.968 centimeters^2 Interval 2.9 to 5.036	1.739 centimeters^2 Interval 0.912 to 2.567

Adverse Events

Broccoli Sprout Extract

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Broccoli Sprout Extract n=30 participants at risk Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions. Broccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge	Placebo n=30 participants at risk Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions. Placebo: 80% acetone
Skin and subcutaneous tissue disorders mild itchy skin or erythema	16.7% 5/30 • Number of events 5	16.7% 5/30 • Number of events 5

Additional Information

Jed W. Fahey, Sc.D.

Johns Hopkins University

Phone: 4106142607

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place