Overview

This trial is active, not recruiting.

Condition alcohol sensitivity
Treatments broccoli sprout extract, placebo
Phase phase 2
Sponsor Paul Talalay, M.D.
Start date April 2014
End date May 2015
Trial size 10 participants
Trial identifier NCT01845220, 81276

Summary

This study is designed to determine whether Asians who are especially sensitive to alcohol exposure can be protected by boosting their activities of an alcohol disposing enzyme. This will be accomplished by administering broccoli sprouts that are rich in an agent that increases protective enzyme activity. The test system involves applying alcohol patches to the skin and measuring skin redness.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
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 Comparator)
Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.
placebo
80% acetone

Primary Outcomes

Measure
Skin Erythema (Skin redness)
time frame: 30 minutes after alcohol skin challenge and every 30 minutes for at least 2 hours.

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - 18-70 years old, - sensitive to alcohol on the skin, Japanese Exclusion Criteria: - recent skin abnormalities /tanning

Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Johns Hopkins University.