Imipramine + Photodynamic Therapy for Actinic Keratosis
Recruiting in Palo Alto (17 mi)
Overseen byCraig Rohan, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Wright State University
Must not be taking: Tricyclics, SSRIs, others
Disqualifiers: Porphyria, Pregnancy, Active rashes, others
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
Yes, if you are currently taking any tricyclic antidepressants (TCAs) or selective serotonin reuptake inhibitors (SSRIs), you will need to stop. Also, if you are taking any oral or topical medications that could interfere with the photodynamic therapy, you will need to stop those as well.
What data supports the effectiveness of the treatment Imipramine + Photodynamic Therapy for Actinic Keratosis?
Photodynamic therapy (PDT) is shown to be an effective and safe treatment for actinic keratosis, especially on the face and scalp, with minimal side effects. While Imipramine is not directly mentioned in the context of actinic keratosis, PDT itself is well-supported by research as a beneficial treatment for this condition.
12345How does the treatment Imipramine + Photodynamic Therapy differ from other treatments for actinic keratosis?
The combination of Imipramine with Photodynamic Therapy (PDT) for actinic keratosis is unique because it potentially introduces a novel mechanism of action by combining a drug typically used for depression with a light-activated treatment. This approach may offer a new way to enhance the effectiveness of PDT, which is already known for being a safe and effective method with minimal side effects compared to other treatments like cryotherapy and topical medications.
12367Eligibility Criteria
This trial is for adults over 18 with fair skin (Fitzpatrick type I to III) who have many pre-cancerous lesions called actinic keratosis and are prescribed photodynamic therapy (PDT) for their face, scalp, or forearms. Participants must avoid excess sun exposure and tanning beds. Excluded are those with porphyria, on certain antidepressants or SSRIs, pregnant or nursing women, people with active rashes or large tattoos in the area, and anyone taking medications that interfere with PDT.Inclusion Criteria
I have a doctor's order for PDT treatment on my face, scalp, or forearms.
I have fair skin, prone to sunburns, Fitzpatrick type I to III.
I will avoid too much sun or using tanning beds on the area treated.
+3 more
Exclusion Criteria
I have porphyria.
I am currently taking tricyclic antidepressants.
I am currently taking an SSRI medication.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive topical Imipramine followed by photodynamic therapy (PDT) to treat actinic keratosis
1 day
1 visit (in-person)
Follow-up
Participants are monitored for changes in itch and pain levels, and the number of precancerous actinic keratosis lesions
6 months
Periodic assessments
Participant Groups
The study tests topical Imipramine applied before PDT to see if it reduces pain from the treatment and improves its effectiveness against actinic keratosis. Both treatments are FDA-approved separately; this trial examines their combined use which hasn't been studied before.
2Treatment groups
Active Control
Placebo Group
Group I: ImipramineActive Control1 Intervention
Topical 4% Imipramine
Group II: VehiclePlacebo Group1 Intervention
Vehicle
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wright State PhysiciansFairborn, OH
Loading ...
Who Is Running the Clinical Trial?
Wright State UniversityLead Sponsor
References
Photodynamic therapy activated by intense pulsed light in the treatment of actinic keratosis. [2021]Actinic keratosis (AK), a hyperkeratotic lesion induced by solar exposure, is the precancerous lesion that most frequently develops into squamous cell carcinoma. Cryotherapy, topical fluorouracil 5, topical diclofenac 3% gel and, more recently, ingenol mebutate are used in addition to surgery. However, these treatments have varying degrees of effectiveness and are not always tolerated due to side effects. In recent years, photodynamic therapy (PDT), has asserted itself as a new effective and safe method for the treatment of actinic keratoses with almost no side effects. The aim of this study is to verify whether a third treatment may now be added to the "Conventional -PDT" and "Daylight-PDT": PhotoDynamic Therapy activated by Intense Pulsed Light (IPL-PDT).
Pharmacological Agents Used in the Prevention and Treatment of Actinic Keratosis: A Review. [2023]Actinic keratosis (AK) is among the most commonly diagnosed skin diseases with potentially life-threatening repercussions if left untreated. Usage of pharmacologic agents represents one of many therapeutic strategies that can be used to help manage these lesions. Ongoing research into these compounds continues to change our clinical understanding as to which agents most benefit particular patient populations. Indeed, factors such as past personal medical history, lesion location and tolerability of therapy only represent a few considerations that clinicians must account for when prescribing appropriate treatment. This review focuses on specific drugs used in either the prevention or treatment of AKs. Nicotinamide, acitretin and topical 5-fluorouracil (5-FU) continue to be used with fidelity in the chemoprevention of actinic keratosis, although some uncertainty persists in regard to which agents should be used in immunocompetent vs. immunodeficient/immunosuppressed patients. Topical 5-FU, including combination formulations with either calcipotriol or salicylic acid, as well as imiquimod, diclofenac and photodynamic light therapy are all accepted treatment strategies employed to target and eliminate AKs. Five percent of 5-FU is regarded as the most effective therapy in the condition, although the literature has conflictingly shown that lower concentrations of the drug might also be as effective. Topical diclofenac (3%) appears to be less efficacious than 5% 5-FU, 3.75-5% imiquimod and photodynamic light therapy despite its favorable side effect profile. Finally, traditional photodynamic light therapy, while painful, appears to be of higher efficacy in comparison to its more tolerable counterpart, daylight phototherapy.
Topical 5-aminolaevulinic acid photodynamic therapy for extensive scalp actinic keratoses. [2019]Scalp actinic keratoses (AKs) are common, particularly in elderly bald males. Cryotherapy and 5-fluorouracil are effective for localized AKs but are limited in extensive disease. Topical 5-aminolaevulinic acid photodynamic therapy (5-ALA PDT) is an alternative. We treated four patients with extensive scalp AKs with low light dose, low dose-rate topical 5-ALA PDT using a broad-spectrum visible light source. Three patients cleared and one showed significant improvement. Remission lasted 6 months.
Italian expert consensus paper on the management of patients with actinic keratoses. [2021]Two round tables involving experts were organized in order to reach a consensus on the management of patients with actinic keratosis (AK). In the first, seven clinical questions were selected and analyzed by a systematic literature review, using a Population, Intervention, Control, and Outcomes framework; in the second, the experts discussed relevant evidences and a consensus statement for each question was developed. Consensus was reached among experts on how to best treat AK patients with respect to different clinical scenarios and special populations. Lesion-directed treatments are preferred in patients with few AKs. Patients with multiple AKs are challenging, with more than one treatment usually needed to achieve complete lesion clearance or a high lesion response rate, therapy should be personalized, based on previous treatments, patient, and lesion characteristics. Methyl aminolevulinate-PDT, DL (day light) PDT, and imiquimod cream were demonstrated to have the lowest percentage of new AKs after post treatment follow-up. For IMQ 5% and 3.75%, a higher intensity of skin reactions is associated with higher efficacy. Photodynamic therapy (PDT) is the most studied treatment for AKs on the arms. Regular sunscreen use helps preventing new AKs. Oral nicotinamide 500 mg twice daily, systemic retinoids and regular sunscreen use were demonstrated to reduce the number of new squamous cell carcinomas in patients with AKs. Limited evidence is available for the treatment of AKs in organ transplant recipients. There is no evidence in favor or against the use of any of the available treatments in patients suffering from hematological cancer.
Current treatments of actinic keratosis. [2022]Actinic keratosis (AK) lesions should be treated because they may evolve into lesions clinically indistinguishable from those of invasive squamous cell carcinoma which require expensive therapy. Treatment options for AK include cryosurgery, curettage and excisional surgery, dermabrasion, chemical peels, laser resurfacing, 5-fluorouracil (5-FU), imiquimod, diclofenac, and tretinoin, each with advantages and limitations. Clinical trial results show that photodynamic therapy (PDT) with 5-aminolevulinic acid (ALA) is an effective and safe treatment of nonhypertrophic AK lesions of the scalp and face. ALA-induced protoporphyrin IX may be activated by a variety of light sources. ALA incubation times of 1-hour make ALA PDT a practical procedure for the treatment of AK lesions. Clinical trials show that PDT with methyl aminolevulinate (MAOP) is also a safe and effective treatment of AKs of the face and scalp; MAOP is available in Europe but not in the US at the time of this writing. ALA PDT offers efficacy against multiple AKs without the adverse effects of 5-FU or imiquimod.
Photodynamic therapy for actinic keratoses. [2016]Actinic keratoses (AKs) are one of the most common conditions that are treated by dermatologists and they have the potential to progress to squamous cell carcinoma if left untreated. Photodynamic therapy (PDT) has emerged as a novel and versatile method of treating those lesions. Topical preparations of aminolevulinic acid and methyl aminolevulinate are commercially available photosensitizers, and numerous light sources may be used for photoactivation. This article focuses on practical aspects of PDT in the treatment of AKs, outcomes of relevant clinical trials, and special applications of PDT in transplant recipients and other who are predisposed to AK formation. Step-by-step descriptions of PDT sessions are presented.
Daylight Photodynamic Therapy Versus 5-Fluorouracil for the Treatment of Actinic Keratosis: A Case Series. [2022]The incidence of actinic keratosis (AK) continues to increase worldwide. Currently available options for the treatment of AK include topical 5-fluorouracil (5-FU) and daylight-mediated photodynamic therapy (DL-PDT). This split-face pilot study compared DL-PDT using 16% methyl aminolevulinate (MAL) cream versus 5-FU cream in patients with AK on the face/scalp.