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Photodynamic Therapy for Actinic Keratosis
Study Summary
This trial will compare the efficacy of two topical treatments for AKs, AMELUZ® gel and LEVULAN® KERASTICK®, using their respective light sources.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- The number of growths or spots on each side of your body cannot be too different from each other.You have used medications that make your skin sensitive to sunlight in the past month.You have a wound, suspicious skin growth, scar, tattoo, or skin condition in the area where the treatment will be given.Your skin type is between very fair and light brown.You have had a treatment called PDT in the area where you want to receive the new treatment in the last 6 months.You have used oral or topical retinoids in the treatment area within the past month.You are overly sensitive to porphyrins.You have been diagnosed with porphyria or photodermatoses.You have mild to moderate AK lesions on both hands or arms, with 4 to 17 lesions in each treatment area.You have recently spent a lot of time in the sun or under UV lights in the treatment area.People between 35 and 85 years old, regardless of gender.You have had laser treatment on your arms within the last year.You had a light or medium skin peel on your arms in the last 30 days.You have had laser or light treatments on your arms in the last 3 months.You need to have a negative pregnancy test before starting the study, and then again on day 30 and day 60.The area to be treated should be able to receive light therapy using specific devices.
- Group 1: Ameluz
- Group 2: Levulan
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA authorized aminolevulinic acid hydrochloride gel, 10% for use?
"Thanks to the Phase 4 classification, aminolevulinic acid hydrochloride gel's safety rating is 3 on a scale from 1 -3. This implies that this particular treatment has already been approved and endorsed by relevant medical authorities."
Is it possible to join this research investigation?
"This research is seeking out 20 people between the ages of 35 and 85 who have cancerous skin lesions. Additional qualifications include: Fitzpatrick Skin type I-IV, consent to HIPAA regulations and photo/informed consent forms, commitment to full course treatment, women of childbearing potential must employ birth control during the study period (e.g., oral contraceptive pill), negative urine pregnancy test results at baseline prior to trial enrollment as well as 30th and 60th day following entry; men or women aged 35-85 with 4-17 clinically confirmed AK lesions of mild to moderate intensity per Olsen grading in two comparable fields on both arms or hands such"
Are the enrollment criteria for this medical study restricted to individuals aged 70 and below?
"As per regulations for this clinical trial, the minimum age of participation lies at 35 years and the maximum cutoff is 85 years."
Are there any opportunities to join this scientific exploration?
"According to the clinicaltrials.gov data, this research trial is not presently accepting patients; initial posting was on May 15th 2022 and it last underwent edits the month prior. However, there are currently 175 other studies actively recruiting participants."
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