Activation of Ameluz With BBL HEROic for the Treatment of Actinic Keratoses and Photodamage (NCT07053852) | Clinical Trial Compass
CompletedPhase 1
Activation of Ameluz With BBL HEROic for the Treatment of Actinic Keratoses and Photodamage
United States10 participantsStarted 2025-06-27
Plain-language summary
To provide a treatment of both actinic keratoses and photodamage within one treatment.
Who can participate
Age range18 Years
SexALL
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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