Overview
To provide a treatment of both actinic keratoses and photodamage within one treatment.
Description
To demonstrate that treatment of actinic keratoses and photodamage with a combination of Ameluz and Broad Band Light (BBL) will lead to an improvement in facial precancerous change and signs of photodamage.
Eligibility
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