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Anti-infective agent
Pentamidine Isethionate for Hypertrophic Scar
Phase 1 & 2
Waitlist Available
Led By Alexander Meves, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (preoperatively) and at weeks 2 and 4.
Awards & highlights
Study Summary
This trial is being done to find out if topical Pentamidine is safe for use in people, and if it can help improve hypertrophic scars.
Eligible Conditions
- Hypertrophic Scar
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (preoperatively), 2 weeks, and 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (preoperatively), 2 weeks, and 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Serious Adverse Events
Secondary outcome measures
Adverse Events
Change in Scar Absolute Depth
Change in Scar Angioplasia
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Topical Pentamidine IsethionateExperimental Treatment1 Intervention
Subjects were randomly assigned to apply topical pentamidine isethionate to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments).
Group II: Placebo ControlPlacebo Group1 Intervention
Subjects were randomly assigned to apply topical placebo to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments). The subject served as their own control.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pentamidine
FDA approved
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,213 Previous Clinical Trials
3,767,005 Total Patients Enrolled
Alexander Meves, MDPrincipal Investigator - Mayo Clinic
Mayo Clinic Hospital-Rochester Saint Marys Campus
University Dusseldorf (Medical School)
Mayo Grad School Med/Mayo Fndn (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have keloid or burn scars.You are currently taking corticosteroids (including inhaled steroids), COX-2 inhibitors, or medications that can strongly affect how other drugs work in your body.You have a scar on your body that is between 5 and 40 centimeters long.You have recently had surgery or a major injury.You are able to undergo surgery to remove a scar safely.You have kidney or liver problems.You have an infection, wound, or skin condition in the treatment area that needs to be healed before participating in the study.Your diabetes is not well controlled (your HbA1C level is higher than 8%) or you have nerve damage in your extremities, or known problems with your blood vessels.You are a smoker or use tobacco products.You have a weakened immune system due to conditions like HIV, cancer, or other diseases that affect your body's ability to fight off infections.You have a serious health condition that is not under control and could affect the study results.
Research Study Groups:
This trial has the following groups:- Group 1: Topical Pentamidine Isethionate
- Group 2: Placebo Control
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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