Recruiting
Phase 1

Imipramine & Photodynamic Therapy

Sponsor:

Wright State University

Code:

NCT05688904

Conditions

Imipramine

Photodynamic Therapy

Actinic Keratosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Imipramine

Vehicle

Study Details

Brief summary:

The purpose of this study is testing the use of topical Imipramine in combination with topical photodynamic therapy's (PDT) effect on pain following treatment. PDT is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis-AKs) on their skin. These are both FDA-approved treatments, but this study is evaluating their use in combination, which has not been evaluated in the past. The investigators have been doing studies using animals that suggest that imipramine might make the PDT less painful and might help it work better. In order to participate, the subject and their dermatologist have decided that they would benefit from PDT to treat their skin due to many AK precancerous lesions. Please note that neither PDT nor imipramine are experimental treatments, but treating their skin with imipramine before PDT is a new approach.

Conditions

Imipramine

Photodynamic Therapy

Actinic Keratosis

Study ID

NCT05688904

Start date

Jan 19, 2023

Status verified date

Aug, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or female ages 18 and older
  • Skin type must be "Fair", Fitzpatrick type I to III, due to the presence of actinic damage in this population.
  • Subjects need to have a physician's order to receive PDT treatment on their face, scalp or forearms.
  • Willing to participate and understand the informed consent document.
  • Willing to avoid excess sun exposure/tanning beds to the area to be treated with PDT.

Exclusion Criteria:

  • Those currently taking any tricyclic antidepressants (TCAs)
  • Those currently taking any selective serotonin reuptake inhibitor (SSRI)
  • Those with porphyria
  • Large tattoos in the treated areas
  • Pregnancy or nursing
  • Taking any oral or topical medications that could interfere with the PDT (Appendix A)
  • Active rashes in the area

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Imipramine

Topical 4% Imipramine

placebo comparator: Vehicle

Vehicle

Interventions

Imipramine

Topical 4% Imipramine

Vehicle

Vehicle

Primary outcome measure

  • Number of precancerous actinic keratosis present from baseline. [ Time Frame: 6 months post PDT treatment ]

Central Contacts and Locations

Central contacts

Locations

Wright State Physicians

Recruiting

Fairborn, Ohio, United States, 45324

Contacts

Pharmacology Translational Unit

937-245-7500

More Information

Sponsor

Wright State University

Last update posted

Aug 20, 2026

Last verified

Aug, 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 2026-08-20.