Actively Recruiting
Pilot Studies Evaluating Topical Imipramine and Amitriptyline Use to Reduce Ultraviolet B Light-Induced Redness in Rosacea Patients
Led by Wright State University · Updated on 2026-02-18
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Rosacea is a common skin condition that causes easy blushing and redness, often worsened by sunlight exposure. Researchers are studying whether topical medications can reduce this sunlight-induced redness and irritation in people with rosacea. This Phase 2 trial aims to evaluate the effects of two topical drugs, imipramine and amitriptyline, on skin redness caused by ultraviolet B (UVB) light. Participants apply either 4% imipramine or 4% amitriptyline on a small area (2x2 cm) of one cheek, while a vehicle (control substance) is applied on the other cheek. There are two experimental groups: one receiving imipramine and vehicle, and the other receiving amitriptyline and vehicle. The treatments are applied directly to the skin, allowing comparison of redness on treated versus untreated areas. During the study, redness levels caused by UVB light will be measured at 10 minutes, 60 minutes, 120 minutes, and 24 hours after treatment application. Researchers will also monitor how well the skin tolerates each medication over these same time points. Participants may be monitored over several visits to assess skin reactions and medication effects. The trial is randomized and double-blind, ensuring unbiased evaluation of the treatments' impact on sunlight-induced redness in rosacea.
CONDITIONS
Brief Title
Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fitzpatrick Skin Type I to IV
- Self-identified rosacea or no history of flushing/blushing for control subjects
- Able to provide medical history and medication list
- Control subjects must not take medications known to increase photosensitivity
You will not qualify if you...
- Using imipramine, amitriptyline, or other tricyclic antidepressants (oral or topical)
- Using topical anti-inflammatory treatments within 1 week or systemic agents like prednisone
- Large tattoos in the testing areas
- Tanning bed use within the last 3 months
- Photodynamic Therapy or UCB treatments in the past 3 months
- Female subjects who are pregnant or nursing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants apply topical 4% imipramine or 4% amitriptyline and vehicle on designated areas of the cheek to evaluate reduction in ultraviolet B light-induced redness.
1 treatment visit with assessments at 10 minutes, 60 minutes, 120 minutes, and 24 hours post-treatment
Trial Site Locations
Total: 1 location
1
Wright State Physicians
Fairborn, Ohio, United States, 45324
Actively Recruiting
Research Team
M
Manager Clinical Research Operations
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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