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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rosacea
• Intervention / Treatment: Drug: Imipramine; Drug: Vehicle; Drug: Amitriptyline

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Manager Clinical Research Operations; Phone Number: (937)-245-7500; Email: pturesearch@wrightstatephysicians.org

Study Locations

• United States
  • Ohio
    • Fairborn, Ohio, United States, 45324
      • Recruiting
      • Wright State Physicians
      • Principal Investigator: Travers
      • Contact: Pharmacology Translational Unit; Phone Number: (937)-245-7500; Email: pturesearch@wrightstatephysicians.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Imipramine; 4% imipramine; Drug: Vehicle; 0.1ml propylene glycol
Experimental: 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.	Drug: Vehicle; 0.1ml propylene glycol; Drug: Amitriptyline; 4% amitriptyline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in redness of Ultraviolet B induced erythema with 4% imipramine	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.	10 minutes post-treatment
Difference in redness of Ultraviolet B induced erythema with 4% imipramine	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.	60 minutes post-treatment
Difference in redness of Ultraviolet B induced erythema with 4% imipramine	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.	120 minutes post-treatment
Difference in redness of Ultraviolet B induced erythema with 4% imipramine	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.	24 hours post-treatment
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline	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.	10 minutes post-treatment
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline	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.	60 minutes post-treatment
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline	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.	120 minutes post-treatment
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline	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.	24 hours post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability of 4% imipramine on facial skin	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]	10 minutes post-treatment
Tolerability of 4% imipramine on facial skin	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]	60 minutes post-treatment
Tolerability of 4% imipramine on facial skin	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]	120 minutes post-treatment
Tolerability of 4% imipramine on facial skin	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]	24 hours post-treatment
Tolerability of 4% amitriptyline on facial skin	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]	10 minutes post-treatment
Tolerability of 4% amitriptyline on facial skin	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]	60 minutes post-treatment
Tolerability of 4% amitriptyline on facial skin	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]	120 minutes post-treatment
Tolerability of 4% amitriptyline on facial skin	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]	24 hours post-treatment

Collaborators and Investigators

• Sponsor: Wright State University

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin and Connective Tissue Diseases; Rosacea; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Hydrocarbons, Cyclic; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Dibenzocycloheptenes; Benzocycloheptenes; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Amitriptyline; Imipramine
• Other Study ID Numbers: 2023-296

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes