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Ameluz · 1 trial · 2 indications
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 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)
| Arm | Type | Description |
|---|---|---|
| Two PDT treatments | EXPERIMENTAL | Each subject will receive 2 treatments of photodynamic therapy using Ameluz and HEROic BBL to treat facial AK and signs of photodamage. |
| Name | Type | Description |
|---|---|---|
| Ameluz | DRUG | broad band light (BBL) with the use of Ameluz |
| Sciton HEROic | DEVICE | Each subject will receive 2 treatments of photodynamic therapy using Ameluz and HEROic BBL to treat facial AK and signs of photodamage. |
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 * Significan...
Ameluz is a small molecule drug used for the treatment of actinic keratoses, a skin condition caused by sun damage. It is also being studied for its effects on photodamage. The drug is applied topically and is currently in clinical development for this dermatological indication.
Ameluz is developed by Biofrontera Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol BFRI. Biofrontera is focused on dermatological treatments, and Ameluz is one of its key investigational products for actinic keratoses.
Ameluz is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for the treatment of actinic keratoses and photodamage, and it is currently undergoing early-stage clinical trials to evaluate its safety and efficacy.
Ameluz has one completed clinical trial registered under NCT07053852. This Phase 1 study, titled 'Activation of Ameluz With BBL HEROic for the Treatment of Actinic Keratoses and Photodamage,' enrolled 10 participants in the United States. The trial was uncontrolled, meaning there was no comparator group, and it included healthy volunteers aged 18 years and older.
No alternative names for Ameluz have been reported. The drug is known by its brand name Ameluz and is being developed by Biofrontera Inc. for the treatment of actinic keratoses. It is a small molecule therapy that is currently in Phase 1 clinical trials.