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

Part of paid clinical trials in Fairborn, Ohio.

Sponsor
Wright State University
Study ID
NCT06312813
Phase
PHASE2
Status
Recruiting

Conditions

  • Rosacea

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 27, 2024
Status verified
Feb 2026
Primary completion
Dec 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Difference in redness of Ultraviolet B induced erythema with 4% imipramine [ Time Frame: 10 minutes post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wright State PhysiciansFairbornOhio45324
Pharmacology Translational Unit
(937)-245-7500
Travers (PRINCIPAL_INVESTIGATOR)

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