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Disinfectant
Alcohol for Skin Infections
Phase 3
Waitlist Available
Led By Anna Taddio, PhD
Research Sponsored by University of Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* healthy pediatric patients undergoing routine vaccinations
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first enrollment until the date of final enrollment, up to 1 year
Awards & highlights
Pivotal Trial
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Summary
Alcohol is used to disinfect the skin prior to injections in order to prevent infections caused by bacteria on the skin being injected within tissue. At present, however, clinical trials do not demonstrate a clinical impact of using or not using alcohol swabs on infections and infection symptoms calling into question the practice of using it prior to all injections. These studies are methodologically flawed, and do not specifically examine vaccine injections. The present study is being undertaken to provide some preliminary data for the risk of infection and infection symptoms when alcohol swabs are not used to perform vaccine injections.
Eligible Conditions
- Skin Infections
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of first enrollment until the date of final enrollment, up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first enrollment until the date of final enrollment, up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Skin infection
Secondary study objectives
Compliance with protocol
Feasibility of protocol
Feasibility of recruitment
+1 moreSide effects data
From 2017 Phase 2 trial • 17 Patients • NCT0177902459%
Increased Appetite
41%
Somnolence
35%
Euphoric mood
29%
Fatigue
12%
Hyperhidrosis
12%
Memory impairment
12%
Dizziness
12%
Nausea
6%
Feeling hot
6%
Flushing
6%
Headache
6%
Decreased appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ghrelin
Placebo
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AlcoholExperimental Treatment1 Intervention
Alcohol will be wiped on the vaccine injection site immediately before vaccine injection.
Group II: No alcoholPlacebo Group1 Intervention
Alcohol will be wiped adjacent to the vaccine injection site immediately before vaccine injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ethanol
FDA approved
Find a Location
Who is running the clinical trial?
University of TorontoLead Sponsor
714 Previous Clinical Trials
1,022,652 Total Patients Enrolled
Anna Taddio, PhDPrincipal InvestigatorUniversity of Toronto
17 Previous Clinical Trials
19,010 Total Patients Enrolled
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