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

NCT ID: NCT06312813

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-27

Study Completion Date

2028-12-01

Brief Summary

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Rosacea is a common skin condition associated with easy blushing and red face; many patients with rosacea react to sunlight with increased redness. The purpose of this study is to determine if the use of a topical medication will help reduce sunlight induced redness and irritation in patients with rosacea.

Detailed Description

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Conditions

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Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Imipramine and Vehicle

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 Type EXPERIMENTAL

Imipramine

Intervention Type DRUG

4% imipramine

Vehicle

Intervention Type DRUG

0.1ml propylene glycol

Amitriptyline and Vehicle

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.

Group Type EXPERIMENTAL

Amitriptyline

Intervention Type DRUG

4% amitriptyline

Vehicle

Intervention Type DRUG

0.1ml propylene glycol

Interventions

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Imipramine

4% imipramine

Intervention Type DRUG

Amitriptyline

4% amitriptyline

Intervention Type DRUG

Vehicle

0.1ml propylene glycol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Fitzpatrick Skin Type I - IIII
* Self-identified rosacea or no history of flushing/blushing for controls
* Able to provide medical history and list of medications -- control subjects will not be allowed to take medications that are known to be photosensitizers.

Exclusion Criteria

* Using imipramine, amitriptyline or any other tricyclic antidepressant (oral or topical)
* Using topical anti-inflammatory (within 1 week) or systemic agents (e.g. prednisone)
* Large tattoos in the designated testing areas
* Tanning bed use within last 3 months
* Photodynamic Therapy or UCB treatments in past 3 months
* Female Subjects: pregnant or nursing
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wright State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Wright State Physicians

Fairborn, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Manager Clinical Research Operations

Role: CONTACT

(937)-245-7500

Facility Contacts

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Pharmacology Translational Unit

Role: primary

937-245-7500

Other Identifiers

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2023-296

Identifier Type: -

Identifier Source: org_study_id

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