Clinical trial NCT06312813: Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea
Official title: Pilot Studies Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Rosacea
Lead sponsor: Wright State University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in redness of Ultraviolet B induced erythema with 4% imipramine
timeFrame: 10 minutes post-treatment
measure: Difference in redness of Ultraviolet B induced erythema with 4% imipramine
timeFrame: 60 minutes post-treatment
measure: Difference in redness of Ultraviolet B induced erythema with 4% imipramine
timeFrame: 120 minutes post-treatment
measure: Difference in redness of Ultraviolet B induced erythema with 4% imipramine
timeFrame: 24 hours post-treatment
measure: Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline
timeFrame: 10 minutes post-treatment
measure: Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline
timeFrame: 60 minutes post-treatment
measure: Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline
timeFrame: 120 minutes post-treatment
measure: Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline
timeFrame: 24 hours post-treatment
Secondary outcomes:
measure: Tolerability of 4% imipramine on facial skin
timeFrame: 10 minutes post-treatment
measure: Tolerability of 4% imipramine on facial skin
timeFrame: 60 minutes post-treatment
measure: Tolerability of 4% imipramine on facial skin
timeFrame: 120 minutes post-treatment
measure: Tolerability of 4% imipramine on facial skin
timeFrame: 24 hours post-treatment
measure: Tolerability of 4% amitriptyline on facial skin
timeFrame: 10 minutes post-treatment
measure: Tolerability of 4% amitriptyline on facial skin
timeFrame: 60 minutes post-treatment
measure: Tolerability of 4% amitriptyline on facial skin
timeFrame: 120 minutes post-treatment
measure: Tolerability of 4% amitriptyline on facial skin
timeFrame: 24 hours post-treatment
Other outcomes:
Locations:
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
Study officials:
References: