Rosacea
Conditions
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.
Interventions
DRUGImipramine
4% imipramine
DRUGAmitriptyline
4% amitriptyline
DRUGVehicle
0.1ml propylene glycol
Sponsors
Wright State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in redness of Ultraviolet B induced erythema with 4% imipramine | 10 minutes post-treatment | 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% amitriptyline | 10 minutes post-treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of 4% imipramine on facial skin | 10 minutes post-treatment | 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% amitriptyline on facial skin | 10 minutes post-treatment | 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. \[0= no skin pain/itch; 10 = severe skin pain/itch\] |
Countries
United States
Contacts
CONTACTManager Clinical Research Operations
Outcome results
None listed