Photodynamic Therapy vs Chemical Peels for Actinic Keratosis

Overseen By Alejandra Onate, M.S.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwestern University

Disqualifiers: Pregnant, Nursing, Extensive skin conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment for actinic keratosis?

Research shows that both photodynamic therapy (using light to activate a drug) and chemical peels (using a chemical solution to remove damaged skin layers) are effective for treating actinic keratosis, a skin condition caused by sun damage. Studies have compared these treatments and found them suitable for large skin areas, with some evidence suggesting that combining treatments may improve results. ^{1 2 3 4 5}

Is photodynamic therapy and chemical peels safe for treating actinic keratosis?

Photodynamic therapy (PDT) is generally considered safe for treating actinic keratosis, with studies showing minimal side effects and good cosmetic results. Chemical peels with trichloroacetic acid (TCA) have been used for a long time, but there is limited research on their safety specifically for actinic keratosis. ^{5 6 7 8 9}

How does photodynamic therapy differ from chemical peels for treating actinic keratosis?

Photodynamic therapy (PDT) uses a special light source to activate a drug applied to the skin, targeting and destroying abnormal cells, while chemical peels use a chemical solution like trichloroacetic acid (TCA) to remove the outer skin layers. PDT can be more targeted and is often used for larger areas, whereas chemical peels have been used for a long time but lack strong evidence for their effectiveness in treating actinic keratosis. ^{5 10 11 12 13}

What is the purpose of this trial?

The purpose of this study is to to compare photodynamic therapy (PDT) versus the combination of Jessner's solution and 35% trichloroacetic acid (TCA) chemical peels for the treatment of actinic keratoses on upper extremities. This is a randomized clinical trial. Approximately 60 participants with actinic keratoses on both upper arms will be randomized to have one arm receive photodynamic therapy, while the contralateral arm receives Jessner's solution followed immediately by 35% TCA. AKs will be counted before treatment and 2-8 weeks after treatment. This study is a pilot study designed to determine the feasibility of this procedure. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.

Research Team

Murad Alam, MD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for adults over 18 in the Chicago area who want to treat actinic keratoses on both upper arms and are in good health. They must understand and sign a consent form. Pregnant or nursing individuals, those with communication issues, or extensive skin conditions like eczema or psoriasis on their arms cannot participate.

Inclusion Criteria

I am older than 18 years.

I want treatment for skin lesions on both of my upper arms.

In good general health as assessed by the investigator

Exclusion Criteria

You have severe skin conditions on your arms that would make it hard for you to receive treatment.

Subject unwilling to sign an IRB approved consent form

I can communicate and cooperate with my doctor without issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either photodynamic therapy or a combination of Jessner's solution and 35% TCA chemical peels on their upper extremities

1 day

1 visit (in-person)

Follow-up

Participants are monitored for the clearance of actinic keratoses 2-8 weeks after treatment

2-8 weeks

1-2 visits (in-person)

Treatment Details

Interventions

• Chemical Peels
• Photodynamic Therapy

Trial Overview The study compares two treatments for actinic keratosis: photodynamic therapy (PDT) on one arm versus a chemical peel using Jessner's solution and trichloroacetic acid (TCA) on the other arm. Each participant receives both treatments, one on each arm, to see which works better.

Participant Groups

Group I: Chemical Peels Active Control 1 Intervention

One upper arm will be exposed to Jessner's Solution AND 35% Trichloroacetic acid peel

Group II: Photodynamic Therapy Active Control 1 Intervention

One upper arm will be exposed to blue light therapy

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

Photodynamic therapy (PDT) using aminolevulinic acid (ALA) is highly effective for clearing actinic keratoses (AKs) on the upper extremities, achieving an 88.7% clearance rate with occlusion after 12 weeks.

Using an occlusive dressing during the ALA treatment significantly enhances efficacy compared to non-occluded treatments, although it also increases the incidence and severity of some side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter, randomized, vehicle-controlled phase 2 study of blue light photodynamic therapy with aminolevulinic acid HCl 20% topical solution for the treatment of actinic keratoses on the upper extremities: the effect of occlusion during the drug incubation period. Schmieder, GJ., Huang, EY., Jarratt, M.[2013]

Photodynamic therapy (PDT) is an effective first-choice treatment for actinic keratoses (AKs), but it can cause significant side effects like pain and inflammation during and after treatment.

This review suggests modifications to the classic PDT procedure, such as omitting curettage and reducing incubation time, which aim to decrease side effects while maintaining treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Counteracting Side-effects of Photodynamic Therapy for Actinic Keratoses. Wulf, HC., Heerfordt, IM.[2023]

References

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

Long-term efficacy and safety of Jessner's solution and 35% trichloroacetic acid vs 5% fluorouracil in the treatment of widespread facial actinic keratoses. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Comparative study of trichloroacetic acid vs. photodynamic therapy with topical 5-aminolevulinic acid for actinic keratosis of the scalp. [2015]

3. Spain pubmed.ncbi.nlm.nih.gov

[Retrospective, descriptive, observational study of treatment of multiple actinic keratoses with topical methyl aminolevulinate and red light: results in clinical practice and correlation with fluorescence imaging]. [2019]

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

Combining field therapies for actinic keratoses: novel approaches that intensify photodynamic therapy. [2013]

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

Randomized controlled trial comparing 35% trichloroacetic acid peel and 5-aminolaevulinic acid photodynamic therapy for treating multiple actinic keratosis. [2022]

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

A multicenter, randomized, vehicle-controlled phase 2 study of blue light photodynamic therapy with aminolevulinic acid HCl 20% topical solution for the treatment of actinic keratoses on the upper extremities: the effect of occlusion during the drug incubation period. [2013]

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

Aminolevulinic acid photodynamic therapy for actinic keratoses/actinic cheilitis/acne: vascular lasers. [2015]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Photodynamic therapy: is it a valuable treatment option for actinic keratoses? [2018]

9. Greece pubmed.ncbi.nlm.nih.gov

Counteracting Side-effects of Photodynamic Therapy for Actinic Keratoses. [2023]

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

Comparison of 10 efficient protocols for photodynamic therapy of actinic keratosis: How relevant are effective light dose and local damage in predicting the complete response rate at 3 months? [2022]

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

Topical photodynamic therapy using intense pulsed light for treatment of actinic keratosis: clinical and histopathologic evaluation. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Chemical peelings for the treatment of actinic keratosis: a systematic review and meta-analysis. [2021]

13. England pubmed.ncbi.nlm.nih.gov

A randomized split-scalp study comparing calcipotriol-assisted methyl aminolaevulinate photodynamic therapy (MAL-PDT) with conventional MAL-PDT for the treatment of actinic keratosis. [2022]