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Vasodilator
Nitroglycerin Paste for Gynecomastia
Phase 3
Waitlist Available
Led By Peter Taub, M.D.
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Pivotal Trial
Summary
This trial is testing whether applying Nitroglycerin paste can help wounds heal better and reduce scarring after breast reduction surgery. The paste works by increasing blood flow to the treated area. Patients will be monitored over time to see how well their wounds heal.
Eligible Conditions
- Gynecomastia
- Slow Healing
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Vancouver Scar Scoring (VSS)
Secondary study objectives
Number of occurrences of wound breakdown
Number of side-effects of Nitroglycerin use
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nitroglycerine pasteExperimental Treatment2 Interventions
The randomized breast will receive Nitroglycerine paste and Dermabond.
Group II: DermabondPlacebo Group1 Intervention
The control breast will receive Dermabond only
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
2-octyl cyanoacrylate
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
903 Previous Clinical Trials
541,767 Total Patients Enrolled
Peter Taub, M.D.Principal InvestigatorIcahn School of Medicine at Mount Sinai
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