Ameluz Activation with BBL HEROic for Actinic Keratoses and Photodamage Treatment
This clinical trial is in phase 1 and aims to test the safety and efficacy of treating actinic keratoses and photodamage with a combination of Ameluz and BBL HEROic. We will measure the clearance of actinic keratoses and evaluate cosmetic outcomes at 1 and 2 months after treatment.
Ameluz
+ Sciton HEROic
Keratosis+3
+ Neoplasms
+ Precancerous Conditions
Treatment Study
Summary
Study start date: June 27, 2025
Actual date on which the first participant was enrolled.This study focuses on finding an effective treatment for actinic keratoses and photodamage on the face. Actinic keratoses are rough, scaly patches on the skin caused by too much sun exposure, and they can sometimes lead to skin cancer. Photodamage refers to skin damage caused by sunlight. The study aims to see if using a combination of a gel called Ameluz and a technique known as Broad Band Light (BBL) can improve these skin conditions. The goal is to reduce precancerous skin changes and repair signs of damage from the sun. Participants in this study will receive the treatment on their facial skin. Ameluz is applied to the skin, and then the area is exposed to Broad Band Light. This combination is expected to enhance the treatment of the skin conditions. The study will monitor the skin's response to this treatment to determine its effectiveness in reducing precancerous changes and repairing sun damage. By understanding how well this combination works, the study hopes to offer a better treatment option for those affected by these skin issues.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Rochester Dermatologic Surgery
Victor, United StatesOpen Rochester Dermatologic Surgery in Google Maps