Short Contact Photodynamic Therapy for Actinic Keratosis

Overseen By Edward V Maytin, M.D. Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Case Comprehensive Cancer Center

Must not be taking: Topical treatments, Cancer therapies

Disqualifiers: Pregnancy, Photosensitivity, Cancer, 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: 6

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether shorter treatment times in photodynamic therapy (PDT) can effectively treat actinic keratoses (AK)—rough, scaly patches on the skin caused by sun damage—while reducing the pain often associated with conventional PDT. Participants will receive a special gel treatment (topical aminolevulinate, 10% ALA gel) followed by red light exposure, with different groups experiencing varying incubation times for the gel. The aim is to determine if these shorter treatments can clear AK lesions and be less painful. Individuals with at least 10 AK lesions on their face who are not using other AK treatments may be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of potentially more effective and less painful AK treatments.

Will I have to stop taking my current medications?

If you are using any topical treatments for your actinic keratoses, you must stop at least one month before joining the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

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

Research shows that the treatment being studied, which combines a special gel and red light, is generally safe for treating actinic keratosis (AK), a common skin condition. The gel, known as 10% ALA, effectively treats AK but may cause mild skin irritation in about 12% of patients, leading to some discomfort.

Photodynamic therapy (PDT) with red light is also a well-known and effective treatment for AK. It is popular because it can treat large skin areas at once and is usually safe.

In summary, both parts of the treatment have a good safety record. While some mild irritation may occur, the treatment is well-tolerated by most people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the short contact photodynamic therapy for actinic keratosis because it offers a potentially quicker and more patient-friendly option compared to traditional treatments. Most existing treatments, like cryotherapy and topical chemotherapy, can be time-consuming and sometimes uncomfortable. This therapy uses a topical 10% aminolevulinic acid (ALA) gel, activated by red light, which may clear lesions after shorter incubation times of just 10, 20, or 60 minutes. This could mean faster treatment sessions with less discomfort, potentially improving patient compliance and outcomes.

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

Research has shown that using a 10% aminolevulinic acid (ALA) gel with red light therapy effectively treats actinic keratosis (AK), a skin condition. This trial will explore different regimens of this treatment, where participants will receive one of the following: Regimen A, with a 10-minute incubation of the ALA gel before red light exposure; Regimen B, with a 20-minute incubation; or Regimen C, with a 60-minute incubation. This treatment is approved in the U.S. for use on the face and scalp, demonstrating its effectiveness. Studies suggest that shorter red light therapy sessions can be almost painless while still effectively clearing AK spots. Another study confirmed that the 10% ALA gel works well for treating AK, even without red light. These findings indicate that shorter treatment sessions might still clear AK spots effectively and with less discomfort. ^{6 7 8 9 10}

Who Is on the Research Team?

Edward V Maytin, M.D. Ph.D.

Principal Investigator

Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with at least 10 actinic keratoses lesions on their face, who are not pregnant or nursing, and have stopped any topical AK treatments for a month. It excludes those undergoing cancer treatment, allergic to the study materials, or with photosensitivity diseases.

Inclusion Criteria

I have at least 10 rough, scaly patches on my face.

I will not become pregnant during the study.

Subjects must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria

I stopped using topical treatments on my AKs at least a month ago.

I am not receiving treatment for another cancer.

Pregnant or nursing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Photodynamic Therapy (PDT) with 10% ALA gel and red light exposure. Incubation periods vary between 10, 20, and 60 minutes.

6 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including lesion clearance and patient satisfaction.

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Red light illumination
• Topical aminolevulinate (10% ALA gel)

Trial Overview The trial tests if shorter contact times using a nanoemulsion (10% ALA gel) before red light exposure in PDT can effectively treat actinic keratosis with less pain. Participants will be randomly assigned to one of three groups based on different incubation times: 10, 20, or 60 minutes.

How Is the Trial Designed?

Group I: Regimen C Experimental Treatment 2 Interventions

Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source

Group II: Regimen B Experimental Treatment 2 Interventions

Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source

Group III: Regimen A Experimental Treatment 2 Interventions

Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source

Red light illumination is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Red Light Therapy for:

• Skin conditions (e.g., wrinkles, psoriasis, acne)
• Hair loss
• Pain relief
• Wound healing

Approved in European Union as Photobiomodulation for:

• Skin conditions (e.g., wrinkles, psoriasis, acne)
• Hair loss
• Pain relief
• Wound healing

Approved in Canada as Low-Level Laser Therapy (LLLT) for:

• Skin conditions (e.g., wrinkles, psoriasis, acne)
• Hair loss
• Pain relief
• Wound healing

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Biofrontera Inc.

Industry Sponsor

Biofrontera, Inc.

Collaborator

Trials

2

Recruited

50+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6440706/

Safety and Efficacy of Aminolevulinic Acid 10% Topical Gel ... ... (ALA) gel (GEL) has been shown to be highly effective for treating actinic keratosis (AK) but has only been studied using red-light activation.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12007660/

Red-Light Photodynamic Therapy with 10% Aminolevulinic ... The present study aims to evaluate the safety, clinical efficacy, and cosmetic outcome of PDT for skin rejuvenation and AK clearance rate, using microneedling- ...

3. jaad.org jaad.org/article/S0190-9622(25)02656-8/fulltext

Red light photodynamic therapy with 10% aminolevulinic ... 10% ALA gel is currently approved for field-directed treatment of actinic keratosis on face and scalp in the US. In Europe, it is additionally ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1572100025002303

Painless PDT using 10% aminolevulinate gel and red light ... Short-contact red light PDT regimens are essentially painless and appear to provide very good AK lesion clearance.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06027619?term=AREA%5BConditionSearch%5D(%22Keratosis%22)&rank=1

Short Contact Protocols to Reduce Pain During 10% ALA ... The goal of this clinical trial is to see if shorter Photodynamic Therapy (PDT) treatment times will still be effective at treating actinic keratoses (AK) while ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06545396

Efficacy And Safety Of Illumination Dose Reduction In Red ... The goal of this clinical trial is to compare the tolerance and efficacy of conventional photodynamic therapy (PDT) with red light versus PDT with red light ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK617062/

Photodynamic Therapy for Dermatologic Conditions - StatPearls PDT is a highly effective and well-tolerated treatment option for actinic keratosis. The ability of PDT to treat large areas of field ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S157210002400317X

Effective treatment of actinic keratosis on the hands with ... The aim of this post-hoc analysis was to evaluate efficacy, safety and participants' satisfaction regarding red light PDT with BF-200 ALA for the treatment of ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10251020/

Safety of photodynamic therapy combined with surgical ... Objective: To investigate the efficacy of photodynamic therapy combined with surgical excision on the prognosis of patients with actinic keratosis (AK) and ...

10. 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.