A Phase 2 interventional study of Imipramine and Amitriptyline in Rosacea, sponsored by Wright State University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by Wright State University · Phase 2, Interventional, and Treatment
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.
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
This study's planned enrollment of 48 is below the median of 61 across 200 interventional studies indexed under Rosacea.
Browse Rosacea studies →Wright State University is the lead sponsor of 39 studies on the registry; 13 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Drug: Imipramine · Drug: 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.
Drug: Amitriptyline · Drug: Vehicle
4% imipramine
4% amitriptyline
0.1ml propylene glycol
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours post-treatment
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. \[0= no skin pain/itch; 10 = severe skin pain/itch\]
Time frame: 10 minutes post-treatment
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. \[0= no skin pain/itch; 10 = severe skin pain/itch\]
Time frame: 60 minutes post-treatment
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. \[0= no skin pain/itch; 10 = severe skin pain/itch\]
Time frame: 120 minutes post-treatment
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. \[0= no skin pain/itch; 10 = severe skin pain/itch\]
Time frame: 24 hours post-treatment
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. \[0= no skin pain/itch; 10 = severe skin pain/itch\]
Time frame: 10 minutes post-treatment
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. \[0= no skin pain/itch; 10 = severe skin pain/itch\]
Time frame: 60 minutes post-treatment
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. \[0= no skin pain/itch; 10 = severe skin pain/itch\]
Time frame: 120 minutes post-treatment
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. \[0= no skin pain/itch; 10 = severe skin pain/itch\]
Time frame: 24 hours post-treatment
Started Feb 2024 (actual). Primary completion is estimated for Dec 2028, 57 months after the start.
Of 20 phase 2 interventional studies under Rosacea, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 16. This study's planned 57 months is above that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Imipramine · Amitriptyline
Wright State University