Photodynamic Therapy Monitoring for Actinic Keratosis

Recruiting in Palo Alto (17 mi)

Overseen by Edward Maytin, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Case Comprehensive Cancer Center

Must not be taking: Topical treatments

Disqualifiers: Pregnancy, Cancer treatment, Photosensitivity, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of the study is to test a new video device for actinic keratoses. The device takes images of your skin lesions during the treatment, to learn whether this device can predict how well the treatment is working.

Will I have to stop taking my current medications?

The trial requires that you stop using any topical treatments on your actinic keratoses at least one month before participating. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What data supports the effectiveness of the treatment Photodynamic Therapy (PDT) for actinic keratosis?

Research shows that Photodynamic Therapy (PDT) is effective for treating actinic keratosis, a skin condition caused by sun damage. Studies indicate that using a special light with a photosensitizer (a substance that makes the skin sensitive to light) can successfully target and treat these skin lesions. ^{1 2 3 4 5}

Is photodynamic therapy (PDT) safe for humans?

Photodynamic therapy (PDT) is generally considered safe for treating actinic keratosis, with common side effects including redness, swelling, and pain during treatment. However, some studies suggest there may be a risk of cancerous changes, so it's important to discuss potential risks with a healthcare provider. ^{2 4 6 7 8}

How is photodynamic therapy different from other treatments for actinic keratosis?

Photodynamic therapy (PDT) is unique because it uses a special cream that makes the skin sensitive to light, and then a specific type of light is used to activate the treatment, targeting and destroying the abnormal skin cells. This approach is minimally invasive and can treat multiple lesions at once, unlike some other treatments that may require more direct removal or application to each lesion. ^{1 2 3 4 9}

Eligibility Criteria

This trial is for individuals who can consent to treatment, have at least 10 Actinic Keratoses (AK) lesions on their arms or legs, and two AK lesions close enough to be imaged together. Pregnant or nursing women, those using topical treatments for AK within the last month, with photosensitivity diseases like porphyria cutanea tarda, allergies to study materials, or undergoing other cancer treatments are excluded.

Inclusion Criteria

Participants must be able to understand and are willing to sign a written informed consent document

I have over 10 skin lesions on my arms or legs, with at least two close together.

Exclusion Criteria

I have stopped any skin treatments for my condition at least a month ago.

I am not and will not become pregnant or breastfeed during the study.

I have a history of a condition that makes my skin sensitive to light.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard red light PDT treatment with topical aminolevulinate. Photos and videos are taken to monitor treatment progress.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment. Remaining lesions are counted.

3 months

1 visit (in-person)

Treatment Details

Interventions

• Photodynamic therapy (PDT) (Other)
• Red light illumination (Other)

Trial Overview The study tests a new video device that captures images of skin lesions during photodynamic therapy (PDT) for actinic keratoses. It involves applying a topical drug called Aminolevulinate followed by red light illumination to see if the device can predict treatment success.

Participant Groups

Group I: Standard PDT + topical aminolevulinate + red light illumination Experimental Treatment 3 Interventions

Standard PDT using topical aminolevulinate followed by red light illumination for actinic keratosis. A region of interest (ROI) on the skin of the arms, hands, legs, or feet will be selected for monitoring. This ROI will be marked and baseline measurements will be taken. The topical drug Levulan (ALA) will be applied to the ROI and other areas being treated, and covered with plastic wrap. Prior to red light illumination, post topical measurements and baseline values will be performed to measure PpIX and sO2. Red light illumination will follow, and sO2 phosphorescence will be recorded continuously from the ROI. After, a post-PpIX measurement will be taken.

Photodynamic therapy (PDT) is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Photodynamic therapy for:

• Actinic keratosis
• Basal cell skin cancer
• Esophageal cancer
• Non-small cell lung cancer
• Squamous cell skin cancer (Stage 0)
• Barrett esophagus
• Advanced cutaneous T-cell lymphoma

🇪🇺 Approved in European Union as Photodynamic therapy for:

• Actinic keratosis
• Basal cell skin cancer
• Esophageal cancer
• Non-small cell lung cancer
• Squamous cell skin cancer (Stage 0)
• Barrett esophagus

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cleveland Clinic, Case Comprehensive Cancer Center Cleveland, OH

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center Lead Sponsor

National Cancer Institute (NCI) Collaborator

National Institutes of Health (NIH) Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

Topical methyl aminolevulinate photodynamic therapy using red light-emitting diode light for multiple actinic keratoses: a randomized study. [2019] Photodynamic therapy (PDT) is an effective treatment for actinic keratoses (AKs). Light-emitting diodes (LEDs) offer practical advantages when treating multiple lesions.

2. Netherlands pubmed.ncbi.nlm.nih.gov

Photodynamic therapy in the management of actinic keratosis: Retrospective evaluation of outcome. [2017] Photodynamic therapy (PDT) is a minimally invasive intervention used in the management of tissue disorders. In this retrospective study, a total of 62 patients with actinic keratosis (AKs) were treated with surface illumination PDT. Comparisons with the clinical features, rate of recurrence as well as malignant transformation and overall outcome were made.

3. Austria pubmed.ncbi.nlm.nih.gov

Photodynamic Therapy for Field Cancerization in the Skin: Where Do We Stand? [2023] Photodynamic therapy (PDT) with a photosensitizer is available for the treatment of multiple actinic keratoses (AKs) in a restricted skin area or, as it is established, for the field-cancerized skin.

4. United States pubmed.ncbi.nlm.nih.gov

Photodynamic therapy with topical methyl aminolevulinate for actinic keratosis: results of a prospective randomized multicenter trial. [2018] Photodynamic therapy (PDT) is a promising new treatment modality for actinic keratoses. Methyl aminolevulinate (MAL) (Metvix, PhotoCure, Oslo, Norway) leads to selective accumulation of photoactive porphyrins in premalignant skin lesions and makes the lesions susceptible to phototoxic effects on illumination with red light.

5. England pubmed.ncbi.nlm.nih.gov

The impact of occlusive vs non-occlusive application of 5-aminolevulinic acid (BF-200 ALA) on the efficacy and tolerability of photodynamic therapy for actinic keratosis on the scalp and face: A prospective within-patient comparison trial. [2021] Photodynamic therapy (PDT) is an effective treatment for actinic keratoses (AK). PDT is usually performed with occlusion of the photosensitizer prior to subsequent illumination.

6. Spain pubmed.ncbi.nlm.nih.gov

[Studies of methyl aminolevulinate photodynamic therapy for actinic keratosis]. [2016] Photodynamic therapy (PDT) for the treatment of actinic keratosis has been shown to be effective and safe in large clinical trials published in the last 5 years. However, evidence has since emerged that raises questions or that introduces new issues, such as the management of field cancerization, fluorescence diagnosis and results in transplant recipients. There also remains a need for more studies comparing PDT to additional treatments. We review the literature on these new topics in PDT.

7. England pubmed.ncbi.nlm.nih.gov

Methyl-aminolevulinic acid photodynamic therapy for actinic keratoses: a useful treatment or a risk factor? A retrospective study. [2018] Photodynamic therapy (PDT) is a non-invasive treatment, used for superficial non-melanoma skin cancer (NMSC) and actinic keratoses (AKs). Although PDT is considered a safe treatment, some authors report that PDT may have carcinogenic risks. We undertook this retrospective study to determine if there is a real risk of carcinogenicity for patients treated with MAL-PDT for AK and which risk factors may increase the rate of the malignant transformation.

8. England pubmed.ncbi.nlm.nih.gov

Topical corticosteroid reduces inflammation without compromising the efficacy of photodynamic therapy for actinic keratoses: a randomized clinical trial. [2016] Photodynamic therapy (PDT) is an effective and established treatment for actinic keratoses (AK) and nonmelanoma skin cancer. The main side-effects of PDT are post-treatment erythema and oedema, and pain during illumination. Severe erythema after PDT enhances the down time associated with the treatment.

9. Netherlands pubmed.ncbi.nlm.nih.gov

Effective fluence and dose at skin depth of daylight and lamp sources for PpIX-based photodynamic therapy. [2023] Skin-based photodynamic therapy (PDT) is used for the clinical treatment of actinic keratosis (AKs) and other skin lesions with continued expansion into the standard of care. Due to the spectral dependency of photosensitizer activation and skin optical fluence, there is a need for more accurate methods to estimate the delivered dose at depth from different PDT light sources and treatment regimens.