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

ConditionRosacea
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWright State University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Imipramine

    Drug

    4% imipramine

  • Amitriptyline

    Drug

    4% amitriptyline

  • Vehicle

    Drug

    0.1ml propylene glycol

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Imipramine and VehicleExperimental treatment 2 interventions
Group B: Amitriptyline and VehicleExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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