Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea
Pilot Studies Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2024
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 27, 2024
CompletedFirst Submitted
Initial submission to the registry
March 8, 2024
CompletedFirst Posted
Study publicly available on registry
March 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
February 18, 2026
February 1, 2026
4.8 years
March 8, 2024
February 17, 2026
Conditions
Outcome Measures
Primary Outcomes (8)
Difference in redness of Ultraviolet B induced erythema 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
Difference in redness of Ultraviolet B induced erythema 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
Difference in redness of Ultraviolet B induced erythema 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
Difference in redness of Ultraviolet B induced erythema 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
Difference in redness of Ultraviolet B induced erythema 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
Difference in redness of Ultraviolet B induced erythema 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
Difference in redness of Ultraviolet B induced erythema 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
Difference in redness of Ultraviolet B induced erythema 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 Outcomes (8)
Tolerability of 4% imipramine on facial skin
10 minutes post-treatment
Tolerability of 4% imipramine on facial skin
60 minutes post-treatment
Tolerability of 4% imipramine on facial skin
120 minutes post-treatment
Tolerability of 4% imipramine on facial skin
24 hours post-treatment
Tolerability of 4% amitriptyline on facial skin
10 minutes post-treatment
- +3 more secondary outcomes
Study Arms (2)
Imipramine and Vehicle
EXPERIMENTAL4% 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.
Amitriptyline and Vehicle
EXPERIMENTAL4% 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wright State Physicians
Fairborn, Ohio, 45324, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2024
First Posted
March 15, 2024
Study Start
February 27, 2024
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
February 18, 2026
Record last verified: 2026-02