Cryotherapy + Red Light PDT for Actinic Keratosis

Overseen By Ashley Reed

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Psoriasis Treatment Center of Central New Jersey

Must not be taking: 5-FU, Imiquimod, Retinoids, others

Disqualifiers: Pregnancy, Uncontrolled major disease, 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: Unknown

Duration: 24 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

40 patients randomized 1:1 to receive cryotherapy followed by 10% ALA gel Red light PDT vs. to 10% ALA gel Red Light PDT followed by cryotherapy.

Will I have to stop taking my current medications?

The trial requires that you stop using certain skin treatments and medications, such as 5-fluorouracil, imiquimod, and systemic retinoids, for a specific period before starting. If you are using any investigational drugs, you must stop them at least 4 weeks before enrolling.

What data supports the effectiveness of the treatment Cryotherapy + Red Light PDT for Actinic Keratosis?

Research shows that photodynamic therapy (PDT) with red light is effective for treating actinic keratosis, with a 14% better chance of clearing lesions compared to cryotherapy alone. This suggests that combining cryotherapy with red light PDT could enhance treatment effectiveness. ^{1 2 3 4 5}

Is the combination of cryotherapy and red light photodynamic therapy safe for treating actinic keratosis?

Photodynamic therapy (PDT) using 5-aminolaevulinic acid (Ameluz) is generally safe for treating actinic keratosis, with common side effects being mild to moderate reactions at the application site. PDT is often preferred due to fewer systemic side effects and better cosmetic outcomes compared to other treatments like cryotherapy. ^{1 2 6 7 8}

How is the treatment of Cryotherapy + Red Light PDT with Ameluz 10% Topical Gel unique for actinic keratosis?

This treatment combines cryotherapy (freezing the lesion) with red light photodynamic therapy (PDT) using Ameluz gel, which is unique because it uses a specific gel formulation to enhance the effectiveness of PDT. This combination aims to improve lesion clearance and cosmetic outcomes compared to traditional methods like cryotherapy or PDT alone. ^{1 2 4 5 9}

Eligibility Criteria

This trial is for individuals with Actinic Keratosis, a skin condition caused by sun damage, affecting the full face. Participants must be suitable for both cryotherapy and red light PDT treatments.

Inclusion Criteria

Able and willing to give written informed consent prior to performance of any study-related procedures

I am not pregnant and will use approved birth control if I can have children.

I have 6-12 mild to severe actinic keratosis spots on my face.

Exclusion Criteria

I haven't had skin treatments like peels or laser in the last 60 days.

I haven't taken retinoids in the last 6 months.

I haven't taken any experimental drugs recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cryotherapy followed by 10% ALA gel Red light PDT or 10% ALA gel Red Light PDT followed by cryotherapy

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ameluz 10% Topical Gel
• Cryotherapy
• Red Light PDT

Trial Overview The study is testing two sequences of treatment: one group receives cryotherapy followed by ALA gel and red light PDT; the other gets ALA gel with red light PDT first, then cryotherapy. There are 40 patients split evenly between the two groups.

Participant Groups

Group I: cryotherapy followed by 10% ALA gel Red light PDT Experimental Treatment 3 Interventions

Group II: 10% ALA gel Red Light PDT followed by cryotherapy Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Psoriasis Treatment Center of Central New Jersey

Lead Sponsor

Trials

18

Recruited

530+

Biofrontera Bioscience GmbH

Industry Sponsor

Trials

12

Recruited

1,900+

Findings from Research

Photodynamic therapy (PDT) is 14% more effective than cryotherapy for achieving complete clearance of actinic keratoses (AKs) on the face and scalp, based on a meta-analysis of 641 participants.

The study analyzed 13 randomized trials and found that PDT not only improves lesion response but also offers favorable cosmetic results and patient satisfaction compared to traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of photodynamic therapy vs other interventions in randomized clinical trials for the treatment of actinic keratoses: a systematic review and meta-analysis. Patel, G., Armstrong, AW., Eisen, DB.[2018]

Photodynamic therapy (PDT) is an effective first-choice treatment for actinic keratoses (AKs), but it can cause significant side effects like pain and inflammation during and after treatment.

This review suggests modifications to the classic PDT procedure, such as omitting curettage and reducing incubation time, which aim to decrease side effects while maintaining treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Counteracting Side-effects of Photodynamic Therapy for Actinic Keratoses. Wulf, HC., Heerfordt, IM.[2023]

In a study of 204 patients with actinic keratosis, photodynamic therapy (PDT) using methyl aminolevulinate showed a 91% lesion response rate, significantly outperforming cryotherapy (68%) and placebo PDT (30%).

PDT not only provided better clinical outcomes but also resulted in superior cosmetic results and higher patient satisfaction compared to cryotherapy, making it a preferred treatment option for patients with widespread lesions or those in cosmetically sensitive areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of photodynamic therapy using topical methyl aminolevulinate (Metvix) with single cycle cryotherapy in patients with actinic keratosis: a prospective, randomized study. Freeman, M., Vinciullo, C., Francis, D., et al.[2019]

The combination of a fractional ablative 2,940nm erbium:yttrium-aluminum-garnet laser with blue light photodynamic therapy (PDT) is a safe and effective treatment for actinic keratoses (AKs), as demonstrated in a clinical experience with six patients.

This laser-assisted drug delivery method offers a promising option for the field treatment of AKs, which are precursors to skin cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional Ablative Laser-Assisted Photodynamic Therapy as Field Treatment for Actinic Keratoses: Our Anecdotal Experience. Wang, JV., Griffin, TD.[2021]

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]

Tirbanibulin 1% ointment is an effective new treatment for actinic keratosis (AK), showing similar efficacy to established treatments like fluorouracil and photodynamic therapy, with an odds ratio of 11.1 for complete clearance.

The systematic review included 46 studies and confirmed that tirbanibulin has a favorable safety profile and can be applied in a single short treatment period, making it a convenient option for patients compared to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Efficacy and Safety of Tirbanibulin for Actinic Keratosis of the Face and Scalp in Europe: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. Heppt, MV., Dykukha, I., Graziadio, S., et al.[2022]

5-aminolaevulinic acid (Ameluz) has been authorized for use in the European Union to treat mild to moderate actinic keratosis on the face and scalp, based on its effectiveness in improving the complete response rate of lesions.

The treatment involves applying the gel to the lesions and surrounding area, followed by illumination with red light, which activates a compound that destroys the target cells; common side effects include local reactions at the application site.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The European Medicines Agency approval of 5-aminolaevulinic acid (Ameluz) for the treatment of actinic keratosis of mild to moderate intensity on the face and scalp: summary of the scientific assessment of the Committee for Medicinal Products for Human Use. Tzogani, K., Straube, M., Hoppe, U., et al.[2018]

Aminolevulinic acid (ALA) and methyl aminolevulinate (MAL) photodynamic therapy (PDT) are highly effective treatments for actinic keratosis (AK) and have shown high clearance rates for these lesions.

MAL/PDT offers advantages over ALA/PDT, including shorter incubation times, greater selectivity, reduced pain, fewer systemic side effects, and better cosmetic outcomes compared to traditional treatments like cryosurgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current methods for photodynamic therapy in the US: comparison of MAL/PDT and ALA/PDT. Lee, PK., Kloser, A.[2016]

Photodynamic therapy (PDT) using a methyl-ester of 5-aminolevulinic acid is effective in treating resistant actinic keratoses (AKs) while also providing excellent cosmetic results, such as improved skin smoothness.

In a case study of an elderly patient, PDT not only removed the AK lesion but also significantly reduced signs of photoaging, including wrinkles, as demonstrated by 3D-profilometry measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Hotline: Facial skin rejuvenation in a patient treated with photodynamic therapy for actinic keratosis. Bruscino, N., Rossi, R., Dindelli, M., et al.[2013]

References

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

Efficacy of photodynamic therapy vs other interventions in randomized clinical trials for the treatment of actinic keratoses: a systematic review and meta-analysis. [2018]

2. Greece pubmed.ncbi.nlm.nih.gov

Counteracting Side-effects of Photodynamic Therapy for Actinic Keratoses. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A comparison of photodynamic therapy using topical methyl aminolevulinate (Metvix) with single cycle cryotherapy in patients with actinic keratosis: a prospective, randomized study. [2019]

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

Fractional Ablative Laser-Assisted Photodynamic Therapy as Field Treatment for Actinic Keratoses: Our Anecdotal Experience. [2021]

5. France pubmed.ncbi.nlm.nih.gov

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

Comparative Efficacy and Safety of Tirbanibulin for Actinic Keratosis of the Face and Scalp in Europe: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The European Medicines Agency approval of 5-aminolaevulinic acid (Ameluz) for the treatment of actinic keratosis of mild to moderate intensity on the face and scalp: summary of the scientific assessment of the Committee for Medicinal Products for Human Use. [2018]

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

Current methods for photodynamic therapy in the US: comparison of MAL/PDT and ALA/PDT. [2016]

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

Therapeutic Hotline: Facial skin rejuvenation in a patient treated with photodynamic therapy for actinic keratosis. [2013]