NCT06312813 · Wright State University
Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea
What this study is 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.
View original scientific description
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.
Interventions
DRUG
Imipramine
4% imipramine
DRUG
Amitriptyline
4% amitriptyline
DRUG
Vehicle
0.1ml propylene glycol
Primary outcome measures
Difference in redness of Ultraviolet B induced erythema with 4% imipramine
Time frame: 10 minutes 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% imipramine
Time frame: 60 minutes 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% imipramine
Time frame: 120 minutes 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% imipramine
Time frame: 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
Time frame: 10 minutes 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.
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline
Time frame: 60 minutes 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.
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline
Time frame: 120 minutes 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.
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Fairborn, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 18, 2026 · Source of record for eligibility and locations