The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWright State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Imipramine
DrugTopical 4% Imipramine
Vehicle
Other interventionVehicle
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: ImipramineActive comparator 1 intervention
Group B: VehiclePlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
6 months post PDT treatmentSecondary outcomes
1
Change in pain level due to photodynamic therapy (PDT) from baseline.
The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain)
Time frame
Immediately post PDT treatment2
Change in pain level due to photodynamic therapy (PDT) from baseline.
The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain)
Time frame
10 minutes post PDT treatment3
Change in pain level due to photodynamic therapy (PDT) from baseline.
The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain)
Time frame
30 minutes post PDT treatment4
Change in pain level due to photodynamic therapy (PDT) from baseline.
The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain)
Time frame
6 months post PDT treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov