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Recruiting NCT06312813

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

Phase II Interventional Rosacea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Imipramine, Amitriptyline, Vehicle.
Who it may be relevant to
Registry conditions: Rosacea. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Drug Imipramine
    4% imipramine
  • Drug Amitriptyline
    4% amitriptyline
  • Drug Vehicle
    0.1ml propylene glycol

Primary outcome measures

  • Difference in redness of Ultraviolet B induced erythema with 4% imipramine [Time frame: 10 minutes post-treatment]
  • Difference in redness of Ultraviolet B induced erythema with 4% imipramine [Time frame: 60 minutes post-treatment]
  • Difference in redness of Ultraviolet B induced erythema with 4% imipramine [Time frame: 120 minutes post-treatment]
  • Difference in redness of Ultraviolet B induced erythema with 4% imipramine [Time frame: 24 hours post-treatment]
  • Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline [Time frame: 10 minutes post-treatment]
  • Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline [Time frame: 60 minutes post-treatment]
  • Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline [Time frame: 120 minutes post-treatment]
  • Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline [Time frame: 24 hours post-treatment]
Secondary outcome measures (8)
  • Tolerability of 4% imipramine on facial skin [Time frame: 10 minutes post-treatment]
  • Tolerability of 4% imipramine on facial skin [Time frame: 60 minutes post-treatment]
  • Tolerability of 4% imipramine on facial skin [Time frame: 120 minutes post-treatment]
  • Tolerability of 4% imipramine on facial skin [Time frame: 24 hours post-treatment]
  • Tolerability of 4% amitriptyline on facial skin [Time frame: 10 minutes post-treatment]
  • Tolerability of 4% amitriptyline on facial skin [Time frame: 60 minutes post-treatment]
  • Tolerability of 4% amitriptyline on facial skin [Time frame: 120 minutes post-treatment]
  • Tolerability of 4% amitriptyline on facial skin [Time frame: 24 hours post-treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Wright State Physicians — Fairborn

Identifiers

NCT: NCT06312813 · 2023-296

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗