Recruiting
Phase 2

Imipramine & Amitriptyline

Sponsor:

Wright State University

Code:

NCT06312813

Conditions

Rosacea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Imipramine

Amitriptyline

Vehicle

Study Details

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.

Conditions

Rosacea

Study ID

NCT06312813

Start date

Feb 27, 2024

Status verified date

Feb, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Imipramine and Vehicle

4% imipramine and vehicle are applied on a 2x2cm2 area of the subject's cheek. The imipramine is applied on one side of the subject's face (cheek) and vehicle is applied on the other side.

experimental: Amitriptyline and Vehicle

4% amitriptyline and vehicle are applied on a 2x2cm2 area of the subject's cheek. The amitriptyline is applied on side of the subject's face (cheek) and vehicle is applied on the other side.

Interventions

Imipramine

4% imipramine

Amitriptyline

4% amitriptyline

Vehicle

0.1ml propylene glycol

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Manager Clinical Research Operations

(937)-245-7500pturesearch@wrightstatephysicians.org

Locations

Wright State Physicians

Recruiting

Fairborn, Ohio, United States, 45324

Contacts

Pharmacology Translational Unit

(937)-245-7500pturesearch@wrightstatephysicians.org

Principal Investigator:

Travers

More Information

Sponsor

Wright State University

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wright State University on 2026-02-18.