Cryotherapy + Red Light PDT for Actinic Keratosis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
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
Prior Safety Data
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.
12345Is 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.
12678How 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.
12459Eligibility 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
I am 18 years old or older.
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.
+2 more
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.
+4 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: cryotherapy followed by 10% ALA gel Red light PDTExperimental Treatment3 Interventions
Group II: 10% ALA gel Red Light PDT followed by cryotherapyExperimental Treatment3 Interventions
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Psoriasis Treatment Center of New JerseyEast Windsor, NJ
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Who Is Running the Clinical Trial?
Psoriasis Treatment Center of Central New JerseyLead Sponsor
Biofrontera Bioscience GmbHIndustry Sponsor
References
Efficacy of photodynamic therapy vs other interventions in randomized clinical trials for the treatment of actinic keratoses: a systematic review and meta-analysis. [2018]IMPORTANCE Photodynamic therapy (PDT) is used extensively to treat actinic keratoses(AKs). An analysis of the effectiveness of PDT compared with other treatments may help physicians decide what role it should play in their own clinical practices.OBJECTIVE To determine the effectiveness of PDT for the treatment of AKs relative to other methods.DATA SOURCES MEDLINE, EMBASE,Web of Knowledge, and Cochrane Central Register. No restrictions on years were placed, and all searches extended to the year of each data base inception. Our search was conducted on March 20, 2013, and included the search terms solar keratosis, actinic keratosis, photodynamic therapy, and photochemotherapy. No restrictions were used for the search string.STUDY SELECTION Only randomized PDT trials that used aminolevulinic acid hydrochloride ormethyl aminolevulinate hydrochloride as stabilizers with 10 or more participants were considered. Two of the authors undertook the search independently.DATA EXTRACTION AND SYNTHESIS Data were extracted independently by the 2 authors.We assessed data quality using the Jadad scoring system and used a random-effects model for pooled data analysis.MAIN OUTCOMES AND MEASURES Primary outcome measures specified a priori were lesion response, cosmetic results, and patient satisfaction after the intervention.RESULTS Our search identified 875 journal articles and meeting abstracts.We excluded 862 owing to lack of adherence to our inclusion criteria or lack of author response to our queries for further information.We assessed 13 studies for inclusion in our final synthesis, of which 4 were eligible for final meta-analysis. The only comparator for which meta-analysis was performed was cryotherapy. The meta-analysis consisted of 641 participants, with a total of 2174 AKs treated with cryotherapy and 2170 AKs treated with PDT. Compared with cryotherapy, the pooled relative risk for the meta-analysis for complete response (lesion clearance) was 1.14 (95%CI, 1.11-1.18) at 3 months after treatment. Visual inspection of a funnel plot revealed no publication bias, which was confirmed by the Begg test (P = .80).CONCLUSIONS AND RELEVANCE Photodynamic therapy has a 14%better chance of complete lesion clearance at 3 months after treatment than cryotherapy for thin AKs on the face and scalp.
Counteracting Side-effects of Photodynamic Therapy for Actinic Keratoses. [2023]Label="BACKGROUND/AIM" NlmCategory="OBJECTIVE">Actinic keratoses (AKs) are precursors of squamous cell carcinomas and early intervention is important. Photodynamic therapy (PDT) is often first-choice treatment for widespread AKs. Classic PDT consists of: Superficial curettage, application of 5-aminolevulinic acid or methyl aminolevulinate, incubation and protoporphyrin IX (PpIX) accumulation under occlusion for 3 hours, followed by illumination with red light-emitting diode light (37 J/cm2). Classic PDT is effective in treating AKs, but side-effects include unpleasant pretreatment, severe pain during illumination, inflammation after treatment, and long waiting time in the clinic.
A comparison of photodynamic therapy using topical methyl aminolevulinate (Metvix) with single cycle cryotherapy in patients with actinic keratosis: a prospective, randomized study. [2019]Actinic keratosis (AK) is a very common condition, which has the potential of progressing to squamous cell carcinoma. The present study is a prospective, randomized study comparing the lesion response, cosmetic outcome, patient satisfaction and tolerability of a new treatment modality, photodynamic therapy (PDT), using topical methyl aminolevulinate (Metvix), with the most commonly used standard therapy for AK, cryotherapy.
Fractional Ablative Laser-Assisted Photodynamic Therapy as Field Treatment for Actinic Keratoses: Our Anecdotal Experience. [2021]Actinic keratoses (AKs) are common skin lesions that are often considered to be precancerous markers for the future development of skin cancers. There are various treatment options, including cryotherapy, imiquimod, 5-fluorouracil, curettage, lasers, and photodynamic therapy (PDT). Laser-assisted drug delivery, using the combination of a fractional ablative laser with PDT, is an effective therapy. Our clinical experience with six patients demonstrates that the combination of fractional ablative 2,940nm erbium:yttrium-aluminum-garnet laser with blue light PDT is safe and effective for the field treatment of AKs. (SKINmed. 2020;18:214-216).
A controlled trial of photodynamic therapy of actinic keratosis comparing different red light sources. [2014]Photodynamic therapy (PDT) using 5-aminolevulinic acid (ALA) with red light is well established for actinic keratosis (AK). Differences have been observed concerning pain and efficacy rates with different red light sources.
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]Actinic keratosis (AK) is a chronic skin condition that may progress to cutaneous squamous cell carcinoma. We conducted a systematic review of efficacy and safety for key treatments for AK of the face and scalp, including the novel 5-day tirbanibulin 1% ointment. MEDLINE, PubMed, Embase, Cochrane Library, clinical trial registries and regulatory body websites were searched. The review included 46 studies, of which 35 studies included interventions commonly used in Europe and were sufficiently homogenous to inform a Bayesian network meta-analysis of complete clearance against topical placebo or vehicle. The network meta-analysis revealed the following odds ratios and 95% credible intervals: cryosurgery 13.4 (6.2-30.3); diclofenac 3% 2.9 (1.9-4.3); fluorouracil 0.5% + salicylic acid 7.6 (4.6-13.5); fluorouracil 4% 30.3 (9.1-144.7); fluorouracil 5% 35.0 (10.2-164.4); imiquimod 3.75% 8.5 (3.5-22.4); imiquimod 5% 17.9 (9.1-36.6); ingenol mebutate 0.015% 12.5 (8.1-19.9); photodynamic therapy with aminolevulinic acid 24.1 (10.9-52.8); photodynamic therapy with methyl aminolevulinate 11.7 (6.0-21.9); tirbanibulin 1% 11.1 (6.2-20.9). Four sensitivity analyses, from studies assessing efficacy after one treatment cycle only, for ≤25 cm2 treatment area, after 8 weeks post-treatment, and with single placebo/vehicle node confirmed the findings from the base case. Safety outcomes were assessed qualitatively. These results suggest that tirbanibulin 1% offers a novel treatment for AK, with a single short treatment period, favourable safety profile and efficacy, in line with existing topical treatments available in Europe.
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]The European Commission has recently issued a marketing authorisation valid throughout the European Union for 5-aminolaevulinic acid (Ameluz). The decision was based on the favorable opinion of the CHMP recommending a marketing authorization for 5-aminolaevulinic acid for treatment of actinic keratosis of mild to moderate intensity on the face and scalp. The active substance is a sensitizer used in photodynamic/radiation therapy (ATC code L01XD04). The gel should cover the lesions and approximately 5 mm of the surrounding area with a film of about 1 mm thickness. The entire treatment area should be illuminated with a red light source, either with a narrow spectrum around 630 nm and a light dose of approximately 37 J/cm(2) or a broader and continuous spectrum in the range between 570 and 670 nm with a light dose between 75 and 200 J/cm(2). One session of photodynamic therapy should be administered for single or multiple lesions. Non- or partially responding lesions should be retreated in a second session 3 months after the first treatment. 5-aminolaevulinic acid is metabolized to protoporphyrin IX, a photoactive compound which accumulates intracellularly in the treated actinic keratosis lesions. Protoporphyrin IX is activated by illumination with red light of a suitable wavelength and energy. In the presence of oxygen, reactive oxygen species are formed which causes damage of cellular components and eventually destroys the target cells. The benefit with 5-aminolaevulinic acid is its ability to improve the complete response rate of actinic keratosis lesions. The most common side effects are reactions at the site of application. The objective of this article is to summarize the scientific review of the application. The detailed scientific assessment report and product information, including the summary of product characteristics (SmPC), are available on the EMA website (www.ema.europa.eu).
Current methods for photodynamic therapy in the US: comparison of MAL/PDT and ALA/PDT. [2016]There is some debate regarding the rate of progression of actinic keratosis (AK) into squamous cell carcinoma (SCC).1-4 However, it is clear that treatment for AK lesions is warranted. Results from numerous studies with aminolevulinic acid (ALA) and methyl aminolevulinate (MAL) photodynamic therapy (PDT) for the treatment of AKs, SCC, and Bowen's disease show high rates of clearance for these lesions. MAL/PDT provides similar efficacy to ALA/PDT with the benefits of shorter incubation times according to the approved FDA labeling, greater selectivity, reduced pain during and immediately following therapy, and fewer systemic side effects. Cosmetic outcomes are better with PDT than with cryosurgery or excisional surgery. A number of case reports show efficacy with ALA/PDT and MAL/PDT for acne, photorejuvenation, and other off-label indications. Side effects with PDT tend to be mild to moderate and transient in nature. Overall, ALA/PDT and MAL/PDT are effective for a variety of skin diseases and conditions. MAL/PDT provides some advantages over ALA/PDT.
Therapeutic Hotline: Facial skin rejuvenation in a patient treated with photodynamic therapy for actinic keratosis. [2013]The aim of the most used treatments of actinic keratoses (AKs) is to avoid the conversion into invasive squamous cell carcinoma through the destruction of the lesion; a lot of therapeutic modalities (imiquimod, 5-fluorouracil, electrosurgery with curettage, cryosurgery) are effective and safe in this field, but not many can do it with excellent cosmetic results like treatment with photodynamic therapy (PDT). We have treated with this technique an old patient, whose AK was resistant to other treatments; the most interesting feature of our case comes from the esthetic effects of the PDT employing a methyl-ester of 5-aminolevulinic acid as topical photosensitizer. This kind of therapy has removed not only the lesion but also the photoaging manifestations like the wrinkles and the ugly lines, leaving a smooth skin, as we have proved with 3D-profilometry technique.