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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test how safe and effective it is to treat early form of cancer cells found in the upper skin layer of the face, using a light-sensitive gel used in combination with a light source. The main questions this trial aims to answer are: * to confirm using laboratory testing, how much of the affected facial skin cancer section the treatment was able to remove, and; * seeing how many participants had no remaining affected facial skin cancer sections after treatment. Participants who qualify will be asked to complete 14 visits in total and will receive a total of two treatments, after voluntarily consent has been given.

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.

What data supports the effectiveness of the treatment Aminolevulinic acid hydrochloride 10% topical gel for skin cancer?

Research shows that photodynamic therapy using aminolevulinic acid (ALA) is effective in treating skin conditions like actinic keratoses and basal cell carcinoma. ALA, when activated by light, helps to reduce the size and number of skin tumors, with studies reporting high success rates and good cosmetic outcomes. ^{1 2 3 4 5}

Is photodynamic therapy with aminolevulinic acid safe for humans?

Photodynamic therapy using aminolevulinic acid (ALA) is generally well tolerated with minor side effects, such as skin reactions at the application site, which are temporary and consistent with its known safety profile. It has been approved for treating actinic keratosis in the US and Europe, indicating a recognized safety standard. ^{1 2 3 6 7}

How is the treatment Aminolevulinic acid hydrochloride 10% topical gel unique for skin cancer?

This treatment is unique because it uses a process called photodynamic therapy (PDT), where the gel is applied to the skin and then activated by light to destroy cancer cells. It is particularly effective for treating actinic keratoses and certain types of skin cancer, offering excellent cosmetic results with minimal side effects. ^{1 2 3 5 8}

Research Team

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

Principal Investigator

Center for Clinical and Cosmetic Research

Eligibility Criteria

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

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

Voluntary written consent required

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Photodynamic therapy of actinic keratoses with topical aminolevulinic acid hydrochloride and fluorescent blue light. [2013]

2. Canada pubmed.ncbi.nlm.nih.gov

Aminolevulinic acid (Levulan) in photodynamic therapy of actinic keratoses. [2017]

3. United States 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. [2013]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Topical 5-aminolevulinic acid-mediated photodynamic therapy for basal cell carcinoma. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

[Photodynamic diagnosis and therapy of neoplasms of the facial skin after topical administration of 5-aminolevulinic acid]. [2015]

6. 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]

7. United States 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. [2022]

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

Photodynamic therapy in dermatology. [2019]