20 Participants Needed

Photodynamic Therapy Monitoring for Actinic Keratosis

EM
Overseen ByEdward Maytin, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Case Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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.12345

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.24678

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.12349

Research Team

EM

Edward Maytin, MD, PhD

Principal Investigator

Cleveland Clinic, Case Comprehensive Cancer Center

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.
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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)
  • Red light illumination
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Standard PDT + topical aminolevulinate + red light illuminationExperimental Treatment3 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

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials
472
Recruited
33,400+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Findings from Research

In a study involving 131 patients with actinic keratoses, photodynamic therapy (PDT) using topical methyl aminolevulinate (MAL) and LED light was found to be significantly more effective than placebo, achieving an 83.3% complete response rate for lesions compared to only 28.7% for the placebo group.
The treatment was well-tolerated, demonstrating that MAL PDT is a promising option for effectively treating multiple actinic keratoses on the face and scalp.
Topical methyl aminolevulinate photodynamic therapy using red light-emitting diode light for multiple actinic keratoses: a randomized study.Szeimies, RM., Matheson, RT., Davis, SA., et al.[2019]
In a study of 62 patients treated with methyl aminolevulinate-photodynamic therapy (MAL-PDT) for actinic keratosis (AKs), 175 out of 178 lesions showed a complete response after 3 years, indicating high efficacy of this treatment.
The study reported a low recurrence rate, with only 8 recurrences after the first treatment and 2 after the second, and only 2 cases of malignant transformation to squamous cell carcinoma, suggesting that MAL-PDT is a safe and effective long-term option for managing AKs.
Photodynamic therapy in the management of actinic keratosis: Retrospective evaluation of outcome.Jerjes, W., Hamdoon, Z., Abdulkareem, AA., et al.[2017]
Photodynamic therapy (PDT) is effective for treating actinic keratoses (AKs) and offers better cosmetic outcomes and patient satisfaction compared to other treatments like imiquimod and 5-fluorouracil, based on a comprehensive review of the literature.
Daylight PDT is preferred by patients over traditional light sources due to its better tolerability, and it shows promising results even as a preventive treatment for high-risk individuals, such as organ transplant recipients.
Photodynamic Therapy for Field Cancerization in the Skin: Where Do We Stand?Bakirtzi, K., Papadimitriou, I., Vakirlis, E., et al.[2023]

References

Topical methyl aminolevulinate photodynamic therapy using red light-emitting diode light for multiple actinic keratoses: a randomized study. [2019]
Photodynamic therapy in the management of actinic keratosis: Retrospective evaluation of outcome. [2017]
Photodynamic Therapy for Field Cancerization in the Skin: Where Do We Stand? [2023]
Photodynamic therapy with topical methyl aminolevulinate for actinic keratosis: results of a prospective randomized multicenter trial. [2018]
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]
[Studies of methyl aminolevulinate photodynamic therapy for actinic keratosis]. [2016]
Methyl-aminolevulinic acid photodynamic therapy for actinic keratoses: a useful treatment or a risk factor? A retrospective study. [2018]
Topical corticosteroid reduces inflammation without compromising the efficacy of photodynamic therapy for actinic keratoses: a randomized clinical trial. [2016]
Effective fluence and dose at skin depth of daylight and lamp sources for PpIX-based photodynamic therapy. [2023]