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

Wright State University

Status and phase: Enrolling; Phase 2

Conditions: Rosacea

Treatments: Drug: Vehicle; Drug: Amitriptyline; Drug: Imipramine

Study type: Interventional

Funder types: Other

Identifiers

NCT06312813

2023-296

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Imipramine and Vehicle

Experimental group

Description:

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.

Treatment:

Drug: Imipramine

Drug: Vehicle

Amitriptyline and Vehicle

Experimental group

Description:

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:

Drug: Amitriptyline

Drug: Vehicle