Photodynamic Therapy for Skin Cancer

Overseen By Clinical Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The Center for Clinical and Cosmetic Research

Disqualifiers: Pregnant, Lactating, Other tumors, 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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for an early form of skin cancer on the face. It uses a special gel, Aminolevulinic acid hydrochloride 10% topical gel, which activates under a specific red light to determine if it can safely and effectively remove cancer cells. Researchers aim to assess the treatment's effectiveness in clearing the affected skin. Suitable candidates have recently been diagnosed with this type of skin cancer and are willing to follow trial instructions and guidelines. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering an opportunity to contribute to important advancements in skin cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you must not use non-approved lotions and creams on the treatment areas.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that a 10% aminolevulinic acid gel is generally safe. Previous studies applied this gel to treat skin spots on the face and scalp. Almost all participants experienced mild skin reactions, such as redness or irritation, which are common with this type of treatment.

The FDA has also approved the gel for treating other skin issues, indicating its safety. While skin reactions are common, they are usually not serious. Prospective trial participants should be aware of these possible reactions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for skin cancer, which often involve surgery, radiation, or traditional chemotherapy, Photodynamic Therapy (PDT) using aminolevulinic acid hydrochloride 10% gel offers a unique approach by using light to activate a medication applied to the skin. This treatment works by targeting cancer cells with a photosensitizing agent that becomes active when exposed to a specific type of light, in this case, red light. Researchers are excited about this method because it provides a non-invasive option that can target cancer cells directly, potentially reducing side effects and improving recovery times compared to conventional methods.

What evidence suggests that this treatment might be an effective treatment for skin cancer?

Studies have shown that a 10% aminolevulinic acid gel combined with light therapy can effectively treat certain skin cancers. In this trial, participants will receive photodynamic therapy (PDT) using a red light dose. This method has successfully treated non-melanoma skin cancers and actinic keratosis, a precancerous skin condition. Research indicates that this treatment can clear lesions on the face and scalp and is generally safe. Healing usually occurs within two weeks, and the cosmetic results are typically good. The gel and light work together to target and destroy cancer cells in the skin. ^{1 3 5 6 7}

Who Is on the Research Team?

Mark S Nestor, M.D., Ph.D.

Principal Investigator

Center for Clinical and Cosmetic Research

Are You a Good Fit for This Trial?

This trial is for individuals with an early stage of skin cancer on the face, known as SCCis. Participants must be willing to attend 14 visits and receive two treatments after giving consent.

Inclusion Criteria

Voluntary written consent required

I am willing to follow the study rules and not use unapproved lotions on treated areas.

Agree to use acceptable forms of birth control. If female, cannot be pregnant before and during the study

Exclusion Criteria

Pregnant or lactating

Sensitive to any of the study treatment ingredients

Chronic medical condition that in the Investigators opinion will interfere in the trial or affect participant safety

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive two treatments on the skin cancer area of the face using a light-sensitive cream in combination with a light source

12 weeks

14 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including laboratory testing of surgery samples and clinical documentation of treatment effects

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aminolevulinic acid hydrochloride 10% topical gel

Trial Overview The study tests a light-sensitive gel called Aminolevulinic acid hydrochloride applied to the affected area, followed by exposure to red light. The aim is to see how well it removes or reduces facial skin cancer sections.

How Is the Trial Designed?

Group I: Photodynamic Therapy (using Red light dose) Experimental Treatment 1 Intervention

20 participants will be enrolled to this arm

Aminolevulinic acid hydrochloride 10% topical gel is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Levulan Kerastick for:

• Actinic keratoses
• Cutaneous squamous cell carcinoma in situ (SCCis)

Approved in European Union as Metvix for:

• Actinic keratoses
• Cutaneous squamous cell carcinoma in situ (SCCis)
• Basal cell carcinoma

Approved in Canada as Aminolevulinic acid hydrochloride 10% topical gel for:

• Actinic keratoses
• Cutaneous squamous cell carcinoma in situ (SCCis)

Who Is Running the Clinical Trial?

The Center for Clinical and Cosmetic Research

Lead Sponsor

Trials

8

Recruited

340+

Biofrontera, Inc.

Collaborator

Trials

2

Recruited

50+

Biofrontera Inc.

Industry Sponsor

Published Research Related to This Trial

Photodynamic therapy using Levulan Kerastick and blue light was effective in treating a 73-year-old man with nevoid basal cell carcinoma syndrome, leading to a reduction in the number and size of his basal cell carcinomas.

The treatment not only improved the appearance of surgical scars but also decreased the rate of new tumor development, suggesting a comprehensive benefit of this therapy for patients with multiple skin cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Broad area photodynamic therapy for treatment of multiple basal cell carcinomas in a patient with nevoid basal cell carcinoma syndrome. Chapas, AM., Gilchrest, BA.[2013]

Photodynamic therapy (PDT) using delta-aminolevulinic acid (ALA) as a photosensitizer has shown high efficacy in treating skin cancers, particularly solar keratoses and superficial basal cell and squamous cell carcinomas.

ALA-induced porphyrins can be visualized under a Wood light, providing a selective method for detecting and outlining skin tumors, which is beneficial for treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy in dermatology. Fritsch, C., Goerz, G., Ruzicka, T.[2019]

In a study involving 36 patients, topical application of 20% aminolevulinic acid (ALA) followed by exposure to blue light resulted in an 88% complete clearance of actinic keratoses (AKs) after 8 weeks, demonstrating high efficacy.

The treatment was conducted in a multicenter, randomized, vehicle-controlled design, confirming that photodynamic therapy with ALA and blue light is a safe and effective option for managing multiple AKs on the face and scalp.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy of actinic keratoses with topical aminolevulinic acid hydrochloride and fluorescent blue light. Jeffes, EW., McCullough, JL., Weinstein, GD., et al.[2013]

Topical application of 5-aminolevulinic acid (5-ALA) enhances the detection of skin tumors through photodynamic diagnosis, revealing tumor-specific fluorescence even in areas not visible before treatment.

In a study involving 8 patients with solar keratoses and basal cell carcinomas, photodynamic therapy using 5-ALA led to a complete response in all solar keratoses and 10 out of 12 basal cell carcinomas within 2 months, indicating its efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Photodynamic diagnosis and therapy of neoplasms of the facial skin after topical administration of 5-aminolevulinic acid]. Lang, S., Baumgartner, R., Struck, R., et al.[2015]

Topical photodynamic therapy using 5-aminolevulinic acid (Levulon) was effective in treating superficial basal cell carcinoma (BCC), achieving a complete response in 77 out of 82 patients, with excellent cosmetic results.

The treatment demonstrated a high overall recurrence-free survival (RFS) rate, with 92.1% at one year and 88.3% at three years, indicating both efficacy and safety for patients undergoing this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical 5-aminolevulinic acid-mediated photodynamic therapy for basal cell carcinoma. Filonenko, E., Kaprin, A., Urlova, A., et al.[2021]

The nanoemulsion-based BF-200 ALA gel enhances the skin's absorption of aminolevulinic acid (ALA) for effective photodynamic therapy (PDT) in treating actinic keratosis, with minimal systemic absorption observed in pharmacokinetic trials involving patients with severe cases.

After applying BF-200 ALA, plasma levels of ALA peaked at 2.5 to 3.3 times above baseline within 3 hours and returned to baseline within 10 hours, indicating that only a small fraction of the drug is absorbed systemically, which aligns with its known safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Pharmacokinetics and Safety of a 10% Aminolevulinic Acid Hydrochloride Nanoemulsion Gel (BF-200 ALA) in Photodynamic Therapy of Patients Extensively Affected With Actinic Keratosis: Results of 2 Maximal Usage Pharmacokinetic Trials. Novak, B., DuBois, J., Chahrour, O., et al.[2022]

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 aminolevulinic acid (ALA) has become a highly effective treatment for actinic keratoses, with the FDA approving Levulan Kerastick as the preferred topical solution.

Levulan is well tolerated by patients and provides excellent cosmetic outcomes with only minor side effects, making it a safe option for treating skin tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aminolevulinic acid (Levulan) in photodynamic therapy of actinic keratoses. Lang, K., Schulte, KW., Ruzicka, T., et al.[2017]

Citations

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

Safety and Efficacy of Aminolevulinic Acid 10% Topical Gel ... GEL was equivalent to SOL for clearing AK lesions on the face and scalp with blue-light PDT; however, SOL caused significantly more local skin reactions.

2. levulanhcp.com levulanhcp.com/efficacy

proven results to treat actinic keratosis (ak) LEVULAN KERASTICK + BLU-U demonstrated significant efficacy with a strong safety profile for patients with minimally to moderately thick AKs of the face, scalp ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1572100025001814

5-aminolevulinic acid photodynamic therapy for the ... Aminolevulinic acid and methyl aminolevulinate equally effective in topical photodynamic therapy for non-melanoma skin cancers. J. Eur. Acad. Dermatol ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05359419

Comparison of Two Modes of Photodynamic Therapy for ... This study will be a prospective clinical trial performed in a single center, with 20 adult subjects presenting 4-17 clinically confirmed, mild to moderate AKs.

5. medicalpolicy.bcbstx.com medicalpolicy.bcbstx.com/content/dam/bcbs/medicalpolicy/pdf/therapy/THE801.027_2024-12-15.pdf

Dermatologic Applications of Photodynamic Therapy (PDT) Healing occurs within 10 to 14 days, with generally acceptable cosmetic results. PDT with topical ALA has been investigated primarily as a.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/020965s016lbl.pdf

This label may not be the latest approved by FDA. For current ... Local skin reactions at the application site were observed in 99% of subjects treated with LEVULAN. KERASTICK topical solution and BLU-U Blue Light Photodynamic ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02137785

Safety and Efficacy Study of Photodynamic Therapy With ... A Phase 3 Study of Photodynamic Therapy With Levulan Kerastick Topical Solution ... Treatment Satisfaction and Acceptability of 20% Aminolevulinic Acid ...