Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea

Rosacea Clinical Trial

Official title:

Pilot Studies Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06312813
• Other study ID #: 2023-296
• Status: Recruiting
• Phase: Phase 2
• Start date: February 27, 2024
• Est. completion date: December 2028

Study information

• Verified date: March 2024
• Source: Wright State University
• Contact: Manager Clinical Research Operations
• Phone: (937)-245-7500
• Email: pturesearch[@]wrightstatephysicians.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• Imipramine
4% imipramine
• Amitriptyline
4% amitriptyline
• Vehicle
0.1ml propylene glycol

Locations

Country	Name	City	State
United States	Wright State Physicians	Fairborn	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Wright State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultraviolet B induced erythema change with 4% imipramine	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.	10 minutes post-treatment
Primary	Ultraviolet B induced erythema change with 4% imipramine	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.	60 minutes post-treatment
Primary	Ultraviolet B induced erythema change with 4% imipramine	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.	120 minutes post-treatment
Primary	Ultraviolet B induced erythema change with 4% imipramine	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.	24 hours post-treatment
Primary	Ultraviolet B induced erythema change with 4% amitriptyline	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.	10 minutes post-treatment
Primary	Ultraviolet B induced erythema change with 4% amitriptyline	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.	60 minutes post-treatment
Primary	Ultraviolet B induced erythema change with 4% amitriptyline	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.	120 minutes post-treatment
Primary	Ultraviolet B induced erythema change with 4% amitriptyline	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.	24 hours post-treatment
Secondary	Tolerability of 4% imipramine on facial skin	The tolerability of 4% imipramine on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch.	10 minutes post-treatment
Secondary	Tolerability of 4% imipramine on facial skin	The tolerability of 4% imipramine on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch.	60 minutes post-treatment
Secondary	Tolerability of 4% imipramine on facial skin	The tolerability of 4% imipramine on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch.	120 minutes post-treatment
Secondary	Tolerability of 4% imipramine on facial skin	The tolerability of 4% imipramine on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch.	24 hours post-treatment
Secondary	Tolerability of 4% amitriptyline on facial skin	The tolerability of 4% amitriptyline on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch.	10 minutes post-treatment
Secondary	Tolerability of 4% amitriptyline on facial skin	The tolerability of 4% amitriptyline on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch.	60 minutes post-treatment
Secondary	Tolerability of 4% amitriptyline on facial skin	The tolerability of 4% amitriptyline on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch.	120 minutes post-treatment
Secondary	Tolerability of 4% amitriptyline on facial skin	The tolerability of 4% amitriptyline on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch.	24 hours post-treatment