NCT05688904

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
22mo left

Started Jan 2023

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Jan 2023Mar 2028

First Submitted

Initial submission to the registry

January 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

January 19, 2023

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

5.1 years

First QC Date

January 9, 2023

Last Update Submit

April 23, 2024

Conditions

ImipraminePhotodynamic TherapyActinic Keratosis

Outcome Measures

Primary Outcomes (1)

  • Number of precancerous actinic keratosis present from baseline.

    Principal investigator assesses this from AK lesion count mapping at baseline and in 6 months.

    6 months post PDT treatment

Secondary Outcomes (8)

  • Change in pain level due to photodynamic therapy (PDT) from baseline.

    Immediately post PDT treatment

  • Change in pain level due to photodynamic therapy (PDT) from baseline.

    10 minutes post PDT treatment

  • Change in pain level due to photodynamic therapy (PDT) from baseline.

    30 minutes post PDT treatment

  • Change in pain level due to photodynamic therapy (PDT) from baseline.

    6 months post PDT treatment

  • Change in itch level due to photodynamic therapy (PDT) from baseline.

    Immediately post PDT treatment

  • +3 more secondary outcomes

Study Arms (2)

Imipramine

ACTIVE COMPARATOR

Topical 4% Imipramine

Drug: Imipramine

Vehicle

PLACEBO COMPARATOR

Vehicle

Other: Vehicle

Interventions

ImipramineDRUG

Topical 4% Imipramine

Imipramine
VehicleOTHER

Vehicle

Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wright State Physicians

Fairborn, Ohio, 45324, United States

RECRUITING

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Imipramine

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Craig Rohan, MD

    Wright State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manager, Clinical Research Operations

CONTACT

937-245-7500pturesearch@wrightstatephysicians.org

Regulatory Specialist

CONTACT

937-245-7500pturesearch@wrightstatephysicians.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 18, 2023

Study Start

January 19, 2023

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

April 24, 2024

Record last verified: 2024-04

Locations

US(1)