Actinic KeratosisPhase 2NCT06778434
The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans
A Phase 2 study testing Imipramine in people with Actinic Keratosis and Imipramine, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to test the use of topical imipramine in combination with topical photodynamic therapy's (PDT) effect on the effectiveness and pain immunosuppression following treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis, Imipramine, Photodynamic Therapy
- What is being tested?
- Imipramine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 30 Mar 2029
- Phase
- Phase 2
- 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
- Adult Males and Females ages 18 and older who are patients at the Dayton VAMC Dermatology clinics
- Skin type must be "Fair", Fitzpatrick type I or II, due to the presence of actinic damage in this population.
- Subjects must have a VA physician's order to receive PDT treatment on their 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.
- Has stable transportation to attend study visits at DVA
Who cannot join
- Currently taking any tricyclic antidepressants (TCAs)
- Currently taking any selective serotonin reuptake inhibitor (SSRI)
- Has Porphyria
- Large tattoos in areas to be tested
- Pregnancy or nursing
- Taking any oral or topical medications that could interfere with the PDT
- Active rashes in the areas
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
Dayton VA Medical Center, Dayton, OH
Dayton, Ohio, 45428
Elizabeth Cates, MPA, (937) 245-7500, elizabeth.cates@wrightstatephysicians.org
Christina B Knisely, MPH, (937) 724-7500, Christina.knisely@wright.edu
About this study
Official title: Acid Sphingomyelinase Inhibition to Mitigate the Environmental Exposure Risks of Ultraviolet Light-Induced Actinic Neoplasia and Squamous Cell Carcinoma in US Veterans
The purpose of this study is to test the use of topical imipramine in combination with topical photodynamic therapy's (PDT) effect on the effectiveness and pain immunosuppression following treatment. PDT is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis or "AK") on their skin. These are both FDA-approved medications, but this study is evaluating their use in combination, which has not been evaluated in the past. The investigators have been doing studies using mice that suggest imipramine might reduce immune system suppression by PDT thus allowing it to work better. Subjects whose provider has decided that they may benefit from PDT to treat their skin due to many AK precancerous lesions will be recruited for this study. Please note that the PDT itself is not experimental, only the imipramine treatment to the skin. There is a separate informed consent for the PDT.
- Conditions
- Actinic Keratosis, Imipramine, Photodynamic Therapy
- Being tested
- Imipramine, Control 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
10% imipramine
Control VehicleOther
polyethylene glycol: dimethyl sulfoxide Solution
| Study group | Role | What they receive |
|---|---|---|
| Imipramine and Control Vehicle on Forearms | Experimental | 10% imipramine and control vehicle (1.5 ml each) are applied on designated separate dorsal forearm. Receives: Drug: Imipramine; Other: Control Vehicle |
| Imipramine and Control Vehicle on Face | Experimental | 10% imipramine and control vehicle (1.5 ml each) are applied on one side of the face for 1 hour. Receives: Drug: Imipramine; Other: Control Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Forearm Arm Only): Difference in areas of Candida antigen skin test results with PDT+ imipramine
Size of skin reactions from baseline values will be obtained following PDT + vehicle/imipramine using calipers.
Measured: 7, 30, 90 days post-PDT treatments
(Forearm Arm Only): Difference in redness of Candida antigen skin test results with PDT+ imipramine
Redness of skin reactions from baseline values will be obtained following PDT + vehicle/imipramine using mexameter device and thermal imaging.
Measured: 7, 30, 90 days post-PDT treatments
Difference in numbers of precancerous AK skin lesions with PDT and imipramine on the face
Differences in baseline values of AK will be obtained following PDT + vehicle/imipramine by counting and mapping on each side of face/scalp.
Measured: 6, 12 months post-PDT treatment
Secondary outcomes (4)
Difference in numbers of precancerous AK skin lesions with PDT and imipramine on the forearms
Differences in baseline values of AK will be obtained following PDT + vehicle/imipramine by counting and mapping each forearm/wrist.
Measured: 6, 12 months post-PDT treatment
(Forearm Arm Only): Difference in gene profile of skin following treatment with PDT + imipramine
Differences in transcriptome RNA values from baseline will be obtained following PDT + vehicle/impramine by use of tissue RNA-seq with a commercial dermal transcriptomal patch.
Measured: 7 days post-PDT treatment
Differences in post-PDT redness with PDT + imipramine
Differences in redness following PDT + imipramine vs PDT + vehicle from baseline values will be obtained using a mexameter device and thermal imaging on face/forearms.
Measured: 10 min, 30 min, 24 hours post-PDT treatments
Differences in post-PDT pain with PDT + imipramine
Differences in pain following PDT + imipramine vs PDT + vehicle from baseline values will be obtained using a visual analog scale on face/forearms.
Measured: 10 min, 30 min, 24 hours post-PDT treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Apr 2025
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jeffrey Travers, MD, Principal investigator, Dayton VA Medical Center, Dayton, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778434
- Sponsor's protocol ID
- ONCE-001-24S
- Other IDs
- IRB-2024-639, IRB-2024-674
- Status last verified
- Dec 2025
- First submitted
- 10 Jan 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acid Sphingomyelinase Inhibition to Mitigate the Environmental Exposure Risks of Ultraviolet Light-Induced Actinic Neoplasia and Squamous Cell Carcinoma in US Veterans
- ClinicalTrials.gov ID
- NCT06778434
- Acronym / sponsor ID
- ONCE-001-24S
- Conditions
- Actinic Keratosis, Imipramine, Photodynamic Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 16 Jan 2025 (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 to test the use of topical imipramine in combination with topical photodynamic therapy's (PDT) effect on the effectiveness and pain immunosuppression following treatment. PDT is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis or "AK") on their skin. These are both FDA-approved medications, but this study is evaluating their use in combination, which has not been evaluated in the past. The investigators have been doing studies using mice that suggest imipramine might reduce immune system suppression by PDT thus allowing it to work better. Subjects whose provider has decided that they may benefit from PDT to treat their skin due to many AK precancerous lesions will be recruited for this study. Please note that the PDT itself is not experimental, only the imipramine treatment to the skin. There is a separate informed consent for the PDT.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imipramine and Control Vehicle on Forearms | Experimental | Drug: Imipramine, Other: Control Vehicle10% imipramine and control vehicle (1.5 ml each) are applied on designated separate dorsal forearm. |
| Imipramine and Control Vehicle on Face | Experimental | Drug: Imipramine, Other: Control Vehicle10% imipramine and control vehicle (1.5 ml each) are applied on one side of the face for 1 hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult Males and Females ages 18 and older who are patients at the Dayton VAMC Dermatology clinics
- Skin type must be "Fair", Fitzpatrick type I or II, due to the presence of actinic damage in this population.
- Subjects must have a VA physician's order to receive PDT treatment on their 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)
- Currently taking any tricyclic antidepressants (TCAs)
- Currently taking any selective serotonin reuptake inhibitor (SSRI)
- Has Porphyria
- Large tattoos in areas to be tested
- 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 |
|---|---|---|
| Imipramine10% imipramine | Drug | Imipramine and Control Vehicle on Face, Imipramine and Control Vehicle on Forearms |
| Control Vehiclepolyethylene glycol: dimethyl sulfoxide Solution | Other | Imipramine and Control Vehicle on Face, Imipramine and Control Vehicle on Forearms |
Primary outcome
(Forearm Arm Only): Difference in areas of Candida antigen skin test results with PDT+ imipramine
Time frame: 7, 30, 90 days post-PDT treatments
Size of skin reactions from baseline values will be obtained following PDT + vehicle/imipramine using calipers.
(Forearm Arm Only): Difference in redness of Candida antigen skin test results with PDT+ imipramine
Time frame: 7, 30, 90 days post-PDT treatments
Redness of skin reactions from baseline values will be obtained following PDT + vehicle/imipramine using mexameter device and thermal imaging.
Difference in numbers of precancerous AK skin lesions with PDT and imipramine on the face
Time frame: 6, 12 months post-PDT treatment
Differences in baseline values of AK will be obtained following PDT + vehicle/imipramine by counting and mapping on each side of face/scalp.
4 secondary outcomes
Difference in numbers of precancerous AK skin lesions with PDT and imipramine on the forearms
Time frame: 6, 12 months post-PDT treatment
(Forearm Arm Only): Difference in gene profile of skin following treatment with PDT + imipramine
Time frame: 7 days post-PDT treatment
Differences in post-PDT redness with PDT + imipramine
Time frame: 10 min, 30 min, 24 hours post-PDT treatments
Differences in post-PDT pain with PDT + imipramine
Time frame: 10 min, 30 min, 24 hours post-PDT treatments
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 22 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Jeffrey Travers, MD principal investigator
Dayton VA Medical Center, Dayton, OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imipramine in people with Actinic Keratosis and Imipramine, run by VA Office of Research and Development 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 6 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 22 Dec 2025. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Craig A Rohan, MD ((937) 245-7500, craig.rohan@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Forearm Arm Only): Difference in areas of Candida antigen skin test results with PDT+ imipramine (time frame: 7, 30, 90 days post-PDT treatments). The study lists 3 primary outcomes in all. 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 22 Dec 2025.