← Back to Search

Tricyclic Antidepressants

Topical Imipramine + Amitriptyline for Rosacea

Phase 2

Recruiting

Research Sponsored by Wright State University

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 24 hours post-treatment

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if a cream can help reduce redness and irritation in patients with rosacea when they are exposed to sunlight."

Who is the study for?

This trial is for individuals with rosacea, a skin condition that causes blushing and redness. Participants should react to sunlight with increased redness. Specific inclusion and exclusion criteria are not provided, but typically these would detail the age range, health status, and any other conditions or medications that might affect participation.

What is being tested?

The study is testing whether applying Imipramine or Amitriptyline creams can reduce sun-induced redness in rosacea patients compared to a control cream (Vehicle). It's likely participants will be randomly assigned to one of the treatments.

What are the potential side effects?

Potential side effects may include local skin reactions like irritation, itching, or worsening of redness where the medication is applied. Systemic side effects are less common with topical treatments but could occur if the medication is absorbed into the body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline

Difference in redness of Ultraviolet B induced erythema with 4% imipramine

Secondary study objectives

Tolerability of 4% amitriptyline on facial skin

Tolerability of 4% imipramine on facial skin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Imipramine and VehicleExperimental Treatment2 Interventions

4% imipramine and vehicle are applied on a 2x2cm2 area of the subject's cheek. The imipramine is applied on one side of the subject's face (cheek) and vehicle is applied on the other side.

Group II: Amitriptyline and VehicleExperimental Treatment2 Interventions

4% amitriptyline and vehicle are applied on a 2x2cm2 area of the subject's cheek. The amitriptyline is applied on side of the subject's face (cheek) and vehicle is applied on the other side.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vehicle

2013

Completed Phase 3

~5070

Imipramine

1994

Completed Phase 4

~390