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Tricyclic Antidepressants

Amitriptyline and Vehicle 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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ultraviolet B induced erythema change with 4% amitriptyline

Ultraviolet B induced erythema change with 4% imipramine

Secondary outcome measures

Tolerability of 4% amitriptyline on facial skin

Tolerability of 4% imipramine on facial skin

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

Amitriptyline

2008

Completed Phase 4

~1710

Vehicle

2013

Completed Phase 3

~5070

Imipramine

1994

Completed Phase 4

~390

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Wright State UniversityLead Sponsor

41 Previous Clinical Trials

54,834 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Imipramine and its vehicle been granted approval by the FDA?

"Imipramine and Vehicle are rated at 2 for safety by our team at Power, as this trial is in Phase 2 with existing safety data but lacking efficacy evidence."

Answered by AI

Are there any available positions for patients in this ongoing clinical trial?

"As per the information on clinicaltrials.gov, this research study is actively seeking participants. It was first published on February 27th, 2024, and last revised on March 8th, 2024."

Answered by AI

What is the current number of individuals who have been granted admission to participate in this clinical study?

"Affirmative. The information on clinicaltrials.gov indicates an ongoing search for participants in this medical study. It was first posted on February 27, 2024, with the most recent update made on March 8, 2024. Enrollment is sought for a total of 48 individuals at one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea

2024. "Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06312813.

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