Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Re… (NCT06312813) | Clinical Trial Compass
RecruitingPhase 2
Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea
United States48 participantsStarted 2024-02-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in redness of Ultraviolet B induced erythema with 4% imipramine
Timeframe: 10 minutes post-treatment
2
Difference in redness of Ultraviolet B induced erythema with 4% imipramine
Timeframe: 60 minutes post-treatment
3
Difference in redness of Ultraviolet B induced erythema with 4% imipramine
Timeframe: 120 minutes post-treatment
4
Difference in redness of Ultraviolet B induced erythema with 4% imipramine
Timeframe: 24 hours post-treatment
5
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline
Timeframe: 10 minutes post-treatment
6
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline
Timeframe: 60 minutes post-treatment
7
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline