Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea
NCT ID: NCT06312813
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
48 participants
INTERVENTIONAL
2024-02-27
2028-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Imipramine
4% imipramine
Vehicle
0.1ml propylene glycol
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.
Amitriptyline
4% amitriptyline
Vehicle
0.1ml propylene glycol
Interventions
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Imipramine
4% imipramine
Amitriptyline
4% amitriptyline
Vehicle
0.1ml propylene glycol
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
Yes
Sponsors
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Wright State University
OTHER
Responsible Party
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Locations
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Wright State Physicians
Fairborn, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-296
Identifier Type: -
Identifier Source: org_study_id
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