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NCT Number: NCT06312813

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

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.

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location status: Recruiting

Location contact

Pharmacology Translational Unit

CONTACT

[email protected]

(937)-245-7500

Travers

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imipramine

Drug

4% imipramine

Amitriptyline

Drug

4% amitriptyline

Vehicle

Drug

0.1ml propylene glycol

Primary outcomes

  1. Difference in redness of Ultraviolet B induced erythema with 4% imipramine

    Time frame: 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.

  2. Difference in redness of Ultraviolet B induced erythema with 4% imipramine

    Time frame: 60 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.

  3. Difference in redness of Ultraviolet B induced erythema with 4% imipramine

    Time frame: 120 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.

  4. Difference in redness of Ultraviolet B induced erythema with 4% imipramine

    Time frame: 24 hours 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.

  5. Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline

    Time frame: 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.

  6. Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline

    Time frame: 60 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.

  7. Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline

    Time frame: 120 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.

  8. Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline

    Time frame: 24 hours 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 outcomes

  1. Tolerability of 4% imipramine on facial skin

    Time frame: 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]

  2. Tolerability of 4% imipramine on facial skin

    Time frame: 60 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]

  3. Tolerability of 4% imipramine on facial skin

    Time frame: 120 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]

  4. Tolerability of 4% imipramine on facial skin

    Time frame: 24 hours 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]

  5. Tolerability of 4% amitriptyline on facial skin

    Time frame: 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]

  6. Tolerability of 4% amitriptyline on facial skin

    Time frame: 60 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]

  7. Tolerability of 4% amitriptyline on facial skin

    Time frame: 120 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]

  8. Tolerability of 4% amitriptyline on facial skin

    Time frame: 24 hours 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]

Study contacts

Contact information is provided by the study sponsor or research team.

Manager Clinical Research Operations

CONTACT

[email protected]

(937)-245-7500

Sponsors and collaborators

Lead sponsor

Wright State University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 15, 2024
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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