About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Imipramine
Drug4% imipramine
Amitriptyline
Drug4% amitriptyline
Vehicle
Drug0.1ml propylene glycol
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
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. \[0= no skin pain/itch; 10 = severe skin pain/itch\]
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. \[0= no skin pain/itch; 10 = severe skin pain/itch\]
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. \[0= no skin pain/itch; 10 = severe skin pain/itch\]
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. \[0= no skin pain/itch; 10 = severe skin pain/itch\]
Sponsors and contacts
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