Photodynamic Therapy for Actinic Keratosis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Keratolytics, Retinoids, others

Disqualifiers: Skin cancer, Pregnancy, Neurological disorders, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment for actinic keratosis, which causes rough, scaly patches on the skin due to excessive sun exposure. The study evaluates the effectiveness of light therapy (blue light therapy) when combined with a special cream (5-aminolevulinic acid or ALA) applied for varying durations. Participants will either receive light therapy immediately or after a one-hour wait following the cream application. Individuals diagnosed with actinic keratosis who are healthy enough for treatment on their face or scalp may be suitable candidates, particularly those residing in the Chicago area. As an unphased trial, this study provides a unique opportunity to enhance understanding and improve treatment options for actinic keratosis.

Will I have to stop taking my current medications?

The trial requires that you stop using certain skin treatments before starting, like keratolytics (skin peeling agents) within 2 days, topical retinoids within 4 weeks, and systemic retinoids within 6 months. Other procedures like cryotherapy and chemical peels also have specific time restrictions.

What prior data suggests that this photodynamic therapy is safe for treating actinic keratosis?

Research has shown that photodynamic therapy using 5-aminolevulinic acid (ALA) and blue light is a well-tolerated treatment for actinic keratosis, a rough, scaly patch on the skin caused by sun exposure. Studies indicate that a 10% ALA gel is effective and generally safe. Most people experience only mild side effects, such as redness or slight swelling at the treatment site, which usually disappear quickly.

One study found that after treatment, 91% of skin patches on the face and scalp cleared up completely. However, the trunk area had a lower clearance rate of 45%, suggesting the treatment works better on certain parts of the body. Overall, ALA with blue light therapy has been used successfully and safely for this condition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about photodynamic therapy with ALA (5-aminolevulinic acid) and blue light for actinic keratosis because it offers a unique approach to treating this skin condition. Unlike other treatments, which often require topical creams or cryotherapy, this method uses a light-sensitive compound (ALA) that, when activated by blue light, targets and destroys damaged skin cells. This treatment has two distinctive approaches: one with zero incubation and another with a one-hour incubation period with ALA before exposure to the blue light. These variations could potentially offer faster and more flexible treatment options compared to traditional methods, which can take longer to show results.

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

This trial will compare different incubation times with ALA (5-aminolevulinic acid) before blue light therapy. Studies have shown that ALA combined with blue light therapy effectively treats actinic keratosis, a skin condition causing rough, scaly patches. Research indicates that after just one treatment, up to 91% of these patches on the face and scalp can completely clear. One study found that this treatment initially cleared 87.88% of patches, with the rate increasing to 89.66% over time. The therapy is effective and considered safe for patients. Clinical experts agree on its use, making it a promising option for those with actinic keratosis. ^{1 2 6 7 8}

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 individuals in the Chicago area with actinic keratosis, suitable for photodynamic therapy on face or scalp. Participants must be adults in good health and able to consent. Excluded are those using certain skin treatments recently, pregnant or breastfeeding women, and anyone unsuitable as per investigator's judgment.

Inclusion Criteria

I can understand and agree to participate in the study.

Your skin type falls within the Fitzpatrick scale categories I to VI.

I have been diagnosed with actinic keratosis.

Exclusion Criteria

I have had 2 or more ALA-PDT treatments in the last 6 months.

I have not had cryotherapy in the last 2 weeks.

Pregnant or breast feeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive blue light 5-aminolevulinic acid (ALA) photodynamic therapy with either zero time or 1 hour incubation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ALA (5-aminolevulinic acid)
• Blue light therapy

Trial Overview The study tests blue light ALA photodynamic therapy for actinic keratosis with different prep times: no incubation versus a 1-hour wait before treatment. It's a randomized pilot study to assess the procedure's feasibility over three visits including screening, treatment, and an 8-week follow-up.

How Is the Trial Designed?

Group I: Zero incubation with ALA (5-aminolevulinic acid) Experimental Treatment 2 Interventions

Subjects will receive zero time of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy.

Group II: One hour incubation with ALA (5-aminolevulinic acid) Experimental Treatment 2 Interventions

Subjects will receive one hour of incubation with ALA (5-aminolevulinic acid) before photodynamic 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

In a study of 88 patients with actinic keratosis, photodynamic therapy using visible light combined with water-filtered infrared light (PD750) resulted in significantly lower pain scores compared to incoherent light (Wa1200L).

Both light sources showed similar efficacy rates for clearing lesions, with complete clearance rates remaining high at 85% to 91% after 1 month and 69% to 85% after 12 months, indicating that while pain levels differed, the effectiveness of treatment was largely comparable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled trial of photodynamic therapy of actinic keratosis comparing different red light sources. Giehl, KA., Kriz, M., Grahovac, M., et al.[2014]

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]

In a study involving 27 patients with actinic keratosis, different doses of red light (70, 100, and 140 J/cm2) for ALA-PDT showed similar efficacy, with complete remission rates of 89% to 92% one month after treatment, indicating that lower doses can be effective.

The study suggests that a red light dose of 70 J/cm2 is sufficient for effective treatment, as it achieved comparable results to higher doses while also potentially reducing treatment-related pain, which was substantial across all doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of 3 different light doses in the treatment of actinic keratosis with 5-aminolevulinic acid photodynamic therapy: a randomized, observer-blinded, intrapatient, comparison study. Radakovic-Fijan, S., Blecha-Thalhammer, U., Kittler, H., et al.[2013]

In a study of 243 patients, photodynamic therapy (PDT) using 20% aminolevulinic acid (ALA) and blue light resulted in a high efficacy rate, with 77% of patients achieving significant lesion clearing by week 8 and 89% by week 12, compared to only 18% and 13% in the placebo group.

The treatment was generally safe, with most side effects like erythema and edema resolving within 1 to 4 weeks, indicating that ALA PDT is a viable option for treating multiple actinic keratoses on the face and scalp.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy with aminolevulinic acid topical solution and visible blue light in the treatment of multiple actinic keratoses of the face and scalp: investigator-blinded, phase 3, multicenter trials. Piacquadio, DJ., Chen, DM., Farber, HF., et al.[2013]

Photodynamic therapy (PDT) using 5-aminolaevulinic acid (ALA) with a newly developed LED system is as effective as traditional incoherent lamps for treating actinic keratosis, showing similar complete remission rates of 84.3% for LEDs and 82.8% for incoherent lamps after 6 weeks.

Both treatment methods resulted in comparable levels of patient satisfaction, pain during treatment, and cosmetic outcomes, indicating that the LED system is a safe and effective alternative for ALA-PDT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro and in vivo comparison of two different light sources for topical photodynamic therapy. Babilas, P., Kohl, E., Maisch, T., et al.[2013]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9197826/

Photodynamic therapy of actinic keratosis with topical 5 ... Eight weeks after a single treatment using 30% ALA, there was total clearing of 91% of lesions on the face and scalp and 45% of lesions, on the trunk and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1572100025000845

Efficacy of 5-aminolevulinic acid photodynamic therapy for ... This study shows ALA-PDT is an effective and safe treatment for OG 3 AK, achieving high initial (87.88%) and sustained (89.66%) complete clearance rates at 3 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9332024/

The Role and Effectiveness of Photodynamic Therapy on ... Studies have shown that all treatments (DL-PDT, C-PDT, BF-200 ALA, MAL-PDT) are effective in patients with AK and can be clinically applied. In ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1572100025001929

Topical 5-aminolevulinic acid photodynamic therapy for ... Topical PDT improves skin hydration and elasticity. It is a promising strategy for photorejuvenation for people aged >70 years.

5. jaadinternational.org jaadinternational.org/article/S2666-3287(25)00022-7/fulltext

Expert consensus-based recommendations on the use of ... This article reports the development and recommendations of the Photodynamic therapy in Actinic Keratosis Treatment (PAKT) Consensus Group.

6. jcadonline.com jcadonline.com/aminolevulinic-acid-march-2019/

Safety and Efficacy of Aminolevulinic Acid 10% Topical Gel ... Photodynamic therapy (PDT) using 10% 5-aminolevulinic acid (ALA) gel (GEL) has been shown to be highly effective for treating actinic keratosis (AK) but has ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2016/208081Orig1s000ClinPharmR.pdf

208081Orig1s000 ... 5-aminolevulinic acid (ALA) in patients with actinic keratosis following topical application of a gel formulation containing 78 mg/g ALA.

8. aetna.com aetna.com/cpb/medical/data/500_599/0567.html

Actinic Keratoses Treatments - Medical Clinical Policy ... The objectives of this study were to evaluate the efficacy, safety and cosmetic outcome of BF-200 ALA (a nanoemulsion formulation containing 10% aminolevulinic ...