Actinic Keratoses, Photodamage
Conditions
Keywords
aging face, actinic keratosis, BBL, PDT, photodynamic therapy
Brief summary
To provide a treatment of both actinic keratoses and photodamage within one treatment.
Detailed 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.
Interventions
DRUGAmeluz
broad band light (BBL) with the use of Ameluz
DEVICESciton HEROic
Each subject will receive 2 treatments of photodynamic therapy using Ameluz and HEROic BBL to treat facial AK and signs of photodamage.
Sponsors
Sciton
Biofrontera Bioscience GmbH
Sherrif Ibrahim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of clearance of actinic keratoses | 2 months | Percentage of actinic keratosis lesion clearance at 1 and 2 months after 2 treatments with the combination of Ameluz and BBL on the face. |
| Cosmetic outcomes | 2 months | Cosmetic outcomes in photoaging of the face evaluated by Subject and Investigator Global Aesthetic Improvement Scale (GAIS) at 1 and 2 months post last PDT. Scale: Very Satisfied (better than expected), Satisfied (as expected), Unsatisfied (worse than expected) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of clearance of actinic keratoses | 2 months | Percentage of actinic keratosis lesion clearance at 1 and 2 months after 2 treatments with the combination of Ameluz and BBL on the face using a Visia camera analysis. |
| Cosmetic outcomes | 2 months | Cosmetic outcomes in photoaging of the face evaluated a Visia camera analysis at 1 and 2 months post last PDT |
Countries
United States
Outcome results
None listed