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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two treatments for actinic keratosis, a skin condition that causes rough, scaly patches from sun exposure. One group will receive photodynamic therapy, which uses blue light to target the affected skin. The other group will undergo a chemical peel with Jessner's solution followed by trichloroacetic acid (TCA). The study seeks to determine which treatment is more effective by counting the patches before and after treatment. Individuals with actinic keratosis on both upper arms who live around Chicago are suitable candidates for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both treatments tested in this trial—chemical peels and photodynamic therapy (PDT)—are safe for treating skin conditions like actinic keratosis, which are rough, scaly patches on the skin.

Studies have found that Jessner's solution with 35% trichloroacetic acid (TCA) peels is generally safe. Specifically, long-term safety has been observed when these peels treat facial actinic keratoses. Side effects are usually minor, such as temporary redness or peeling of the skin.

Similarly, photodynamic therapy is well-tolerated. Research indicates it is a safe option for treating large areas of skin affected by actinic keratosis. It has proven effective, with mild side effects like temporary pain or redness at the treatment site.

Both treatments have been used in medical settings, and evidence supports their safety. Participants should expect mild and temporary skin reactions as the most common side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for actinic keratosis involve topical creams or freezing the lesions with liquid nitrogen. However, researchers are excited about photodynamic therapy because it uses a unique mechanism involving blue light to activate a photosensitizing agent, targeting the damaged cells directly. This method can be less invasive and might offer quicker recovery times. Chemical peels, on the other hand, use a combination of Jessner's Solution and 35% Trichloroacetic acid to remove the damaged skin layers, promoting new, healthy skin growth. Both treatments provide potentially more precise control and effectiveness compared to traditional methods, which is an exciting development for patients and clinicians alike.

What evidence suggests that this trial's treatments could be effective for actinic keratosis?

This trial will compare Photodynamic Therapy (PDT) with Chemical Peels for treating actinic keratoses (AKs). Studies have shown that PDT effectively treats superficial AKs, which are rough patches on the skin caused by sun damage. Research indicates that PDT also works well for some thicker or more difficult-to-treat AKs. In this trial, one group will receive PDT. Conversely, Chemical Peels using Jessner's solution and trichloroacetic acid (TCA) have also reduced AKs, though some studies suggest they might not be as effective as PDT. Participants in another group will receive Chemical Peels. Both treatments have reduced the number of AKs, but PDT might be more effective. ^{2 3 5 6 7}

Who Is on the Research Team?

Murad Alam, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9145962/

Long-term efficacy and safety of Jessner's solution and 35 ... Improvements in biopsies of clinically actinically damaged skin were seen in keratinocytic atypia, hyperkeratosis, parakeratosis, and inflammation at all ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jdv.16844

Chemical peelings for the treatment of actinic keratosis: a ... Trichloroacetic acid showed significantly lower mean lesion reduction rates per patient in comparison to conventional PDT (MD −20.48, 95% CI: − ...

3. scholarlycommons.henryford.com scholarlycommons.henryford.com/cgi/viewcontent.cgi?article=1606&context=dermatology_articles

Chemical Peels as Field Therapy for Actinic Keratoses The efficacy of glycolic acid peels for the treatment of AKs was studied in a split-face study with 18 patients.9 Glycolic acid was applied on ...

4. mdedge.com mdedge.com/edermatologynews/article/248341/actinic-keratosis/literature-review-highlights-benefits-chemical

Literature review highlights benefits of chemical peels for ... Overall, the studies showed efficacy of peels in reducing AK counts, with minimal adverse events. In the glycolic acid study, 70% glycolic acid ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04429308

PDT vs Peels for Treatment of Actinic Keratoses 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8423570/

Trichloroacetic Acid Peeling for Treating Photoaging This evidence suggests that TCA peeling is effective in photoaging treatment, either as monotherapy or as combination therapy with other modalities.

7. journals.lww.com journals.lww.com/dermatologicsurgery/fulltext/1997/03000/long_term_efficacy_and_safety_of_jessner_s.9.aspx

Long-Term Efficacy and Safety of Jessner's Solution and ... Fifteen patients with severe facial actinic damage were treated on the left fide with a single application of Jessner's solution arid 35% trichloroacetic acid ...