ImipraminePhase 1NCT05688904
The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy
A Phase 1 study testing Imipramine in people with Imipramine and Photodynamic Therapy, run by Wright State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Imipramine, Photodynamic Therapy, Actinic Keratosis
- What is being tested?
- Imipramine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2023to Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wright State Physicians
Fairborn, Ohio, 45324
Pharmacology Translational Unit, 937-245-7500
About this study
Official title: Pilot Studies Testing the Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy
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
- Being tested
- Imipramine, Vehicle
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImipramineDrug
Topical 4% Imipramine
VehicleOther
Vehicle
| Study group | Role | What they receive |
|---|---|---|
| Imipramine | Active comparator | Topical 4% Imipramine Receives: Drug: Imipramine |
| Vehicle | Placebo comparator | Vehicle Receives: Other: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of precancerous actinic keratosis present from baseline.
Principal investigator assesses this from AK lesion count mapping at baseline and in 6 months.
Measured: 6 months post PDT treatment
Secondary outcomes (8)
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)
Measured: Immediately post PDT treatment
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)
Measured: 10 minutes post PDT treatment
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)
Measured: 30 minutes post PDT treatment
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)
Measured: 6 months post PDT treatment
Change in itch level due to photodynamic therapy (PDT) from baseline.
The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch)
Measured: Immediately post PDT treatment
Change in itch level due to photodynamic therapy (PDT) from baseline.
The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch)
Measured: 10 minutes post PDT treatment
Change in itch level due to photodynamic therapy (PDT) from baseline.
The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch)
Measured: 30 minutes post PDT treatment
Change in itch level due to photodynamic therapy (PDT) from baseline.
The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch)
Measured: 6 months post PDT treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start19 Jan 2023
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImipramineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wright State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Craig Rohan, MD, Principal investigator, Wright State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688904
- Sponsor's protocol ID
- 07286
- Status last verified
- Aug 2026
- First submitted
- 9 Jan 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Studies Testing the Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy
- ClinicalTrials.gov ID
- NCT05688904
- Acronym / sponsor ID
- 07286
- Conditions
- Imipramine, Photodynamic Therapy, Actinic Keratosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imipramine | Active comparator | Drug: ImipramineTopical 4% Imipramine |
| Vehicle | Placebo comparator | Other: VehicleVehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImipramineTopical 4% Imipramine | Drug | Imipramine |
| VehicleVehicle | Other | Vehicle |
Primary outcome
Number of precancerous actinic keratosis present from baseline.
Time frame: 6 months post PDT treatment
Principal investigator assesses this from AK lesion count mapping at baseline and in 6 months.
8 secondary outcomes
Change in pain level due to photodynamic therapy (PDT) from baseline.
Time frame: Immediately post PDT treatment
Change in pain level due to photodynamic therapy (PDT) from baseline.
Time frame: 10 minutes post PDT treatment
Change in pain level due to photodynamic therapy (PDT) from baseline.
Time frame: 30 minutes post PDT treatment
Change in pain level due to photodynamic therapy (PDT) from baseline.
Time frame: 6 months post PDT treatment
Change in itch level due to photodynamic therapy (PDT) from baseline.
Time frame: Immediately post PDT treatment
Change in itch level due to photodynamic therapy (PDT) from baseline.
Time frame: 10 minutes post PDT treatment
Change in itch level due to photodynamic therapy (PDT) from baseline.
Time frame: 30 minutes post PDT treatment
Change in itch level due to photodynamic therapy (PDT) from baseline.
Time frame: 6 months post PDT treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
Related trials for Imipramine
RecruitingPhase 2
Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea
Rosacea
RecruitingPhase 2
The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans
Actinic Keratosis, Imipramine
RecruitingPhase 2
Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma
Glioblastoma
RecruitingPhase 1
Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects
Photosensitivity, Microvesicle Particle
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Craig Rohan, MD principal investigator
Wright State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Imipramine in people with Imipramine and Photodynamic Therapy, run by Wright State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manager, Clinical Research Operations (937-245-7500, pturesearch@wrightstatephysicians.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of precancerous actinic keratosis present from baseline. (time frame: 6 months post PDT treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.