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

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a randomized clinical trial evaluating blue light 5-aminolevulinic acid (ALA) photodynamic therapy with different incubation times for the treatment of actinic keratosis. Subjects who are interested in participating, currently living in the Chicago metropolitan area, and meet inclusion and exclusion criteria will be enrolled in the study. Subjects will be randomized to either 1) zero time ALA incubation or 2) 1 hour ALA incubation. Demographic and health data will be collected prior to treatment initiation. Three visits will be conducted: screening, treatment, and follow up visit at 8 weeks. This study is a pilot study designed to determine feasibility of this procedure.

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.

Is photodynamic therapy with aminolevulinic acid safe for humans?

Photodynamic therapy using aminolevulinic acid (ALA) and blue light has been shown to be safe for treating actinic keratosis, a skin condition, in several studies. These studies report that the treatment is generally well-tolerated by patients. ^{1 2 3 4 5}

How is photodynamic therapy with ALA and blue light unique for treating actinic keratosis?

Photodynamic therapy using 5-aminolevulinic acid (ALA) and blue light is unique because it involves applying a special cream (ALA) that makes the skin sensitive to light, followed by exposure to blue light to destroy abnormal skin cells, offering a non-invasive option compared to traditional treatments like surgery or freezing. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment ALA (5-aminolevulinic acid) with blue light therapy for actinic keratosis?

Research shows that using ALA with blue light therapy is effective in clearing actinic keratosis (AK) lesions, especially on the face, scalp, and upper extremities. Studies have demonstrated long-term success with low recurrence rates up to four years after treatment. ^{1 3 4 7 10}

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 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]

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]

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]

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

Photodynamic therapy of actinic keratosis with topical 5-aminolevulinic acid. A pilot dose-ranging study. [2013]

2. United States 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. [2013]

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

Aminolevulinic acid hydrochloride with photodynamic therapy: efficacy outcomes and recurrence 4 years after treatment. [2013]

4. France pubmed.ncbi.nlm.nih.gov

A controlled trial of photodynamic therapy of actinic keratosis comparing different red light sources. [2014]

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

A Randomized, Vehicle-Controlled Phase 3 Study of Aminolevulinic Acid Photodynamic Therapy for the Treatment of Actinic Keratoses on the Upper Extremities. [2019]

6. United States 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. [2013]

7. 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]

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

In vitro and in vivo comparison of two different light sources for topical photodynamic therapy. [2013]

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

Split-face comparison of photodynamic therapy with 5-aminolevulinic acid and intense pulsed light versus intense pulsed light alone for photodamage. [2013]

10. England pubmed.ncbi.nlm.nih.gov

Irradiance and light dose influence histological localization of photodamage induced by photodynamic therapy with aminolaevulinic acid. [2013]