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

Phase 2

Recruiting

• Conditions: Rosacea
• Interventions: Drug: Imipramine; Drug: Amitriptyline; Drug: Vehicle

• Registration Number: NCT06312813
• Lead Sponsor: Wright State University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2024-02-27
• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-08
• Study First Posted: 2024-03-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-27
• Primary Completion: 2028-12-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Imipramine and Vehicle	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.
Amitriptyline and Vehicle	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.
Imipramine and Vehicle	Imipramine	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.
Amitriptyline and Vehicle	Amitriptyline	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.

Primary Outcome Measures

Name	Time	Method
Difference in redness of Ultraviolet B induced erythema with 4% imipramine	24 hours post-treatment	Erythema change from baseline with 4% imipramine application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline	24 hours post-treatment	Erythema change from baseline with 4% amitriptyline application in response to a low level of UVB are measured by using a mexameter device and thermal photography.

Secondary Outcome Measures

Name	Time	Method
Tolerability of 4% imipramine on facial skin	24 hours post-treatment	The tolerability of 4% imipramine on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch. \[0= no skin pain/itch; 10 = severe skin pain/itch\]
Tolerability of 4% amitriptyline on facial skin	24 hours post-treatment	The tolerability of 4% amitriptyline on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch. \[0= no skin pain/itch; 10 = severe skin pain/itch\]

Trial Locations

Locations (1)

Wright State Physicians; 🇺🇸 Fairborn, Ohio, United States