Activation of Ameluz With BBL HEROic for the Treatment of Actinic Keratoses and Photodamage

Launched by SHERRIF IBRAHIM · Jun 26, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new way to treat sun-damaged skin and actinic keratoses, which are rough, scaly patches that can develop from too much sun exposure and may sometimes lead to skin cancer. The treatment combines a special light therapy with a medication called Ameluz to see if it can improve both the damaged skin and these patches in one visit.

Adults over 18 who have visible signs of sun damage and mild to moderate actinic keratoses on their face may be eligible to join. This includes changes like uneven skin color, small red blood vessels, rough or wrinkled skin, and sun-related brown spots. Participants should be willing to attend all study visits and follow the guidelines, including stopping certain skin treatments beforehand. Pregnant individuals or those undergoing cancer treatments are not eligible. If you take part, you can expect to receive the combined treatment and have your skin closely monitored to see how well it works and how safe it is. This study is currently recruiting volunteers who want to help find better options for treating sun-damaged skin.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Over 18yrs of age
• • Willingness to participate in all required study activities and visits
• • Willingness to sign the informed consent form
• • Visible and palpable signs of diffuse actinic damage and actinic keratoses of mild to moderate severity located on the face
• * Significant signs of photoaging, evaluated by investigator, that include any or all the following:
• • Dyspigmentation
• • Solar lentigines
• • Telangiectasias
• • Diffuse erythema
• • Roughness and other textural changes
• • Fine lines
• • Wrinkles
• • Actinic bronzing
• Exclusion Criteria:
• • Subject who is unable and unwilling to provide consent for study schedule and procedures
• • Subject who is pregnant or trying to become pregnant during the study
• • Subjects using any topical treatment on their AKs; must stop at least one month prior
• • Subjects currently undergoing cancer treatment with medical or radiation therapy
• • Subjects with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material
• • Subjects with history of a photosensitivity disease, such as porphyria cutanea tarda