(n=55)
of people were 100% cleared after 12 weeks
(12 weeks after the last treatment) (n=32)
of people achieved 100% clearance with placebo
of people who were cleared after 12 weeks remained completely clear from all AK 1 year after the last PDT (n=50)2
87 people presenting with 4 to 8 mild-to-moderate AK spots on the face/forehead and/or scalp were treated with AMELUZ® or a placebo gel (a gel without medicine) and BF-RhodoLED® red light. Participants received a maximum of 2 PDT treatments and were examined 12 weeks and 1 year after the last treatment.1,3
RhodoLED® XL and BF-RhodoLED® are approved as interchangeable light sources.1
Most side effects occurred during illumination or shortly afterwards, were generally of mild or moderate intensity, and lasted for 1 to 4 days in most cases; in some cases they persisted for 1 to 2 weeks or even longer.
(n=55)
of people were 100% cleared after 12 weeks
(12 weeks after the last treatment) (n=32)
of people achieved 100% clearance with placebo
of people who were cleared after 12 weeks remained completely clear from all AK 1 year after the last PDT (n=50)2
87 people presenting with 4 to 8 mild-to-moderate AK spots on the face/forehead and/or scalp were treated with AMELUZ® or a placebo gel (a gel without medicine) and BF-RhodoLED® red light. Participants received a maximum of 2 PDT treatments and were examined 12 weeks and 1 year after the last treatment.1,3
RhodoLED® XL and BF-RhodoLED® are approved as interchangeable light sources.1
Most side effects occurred during illumination or shortly afterwards, were generally of mild or moderate intensity, and lasted for 1 to 4 days in most cases; in some cases they persisted for 1 to 2 weeks or even longer.
(n=55)
of people were 100% cleared after 12 weeks
(12 weeks after the last treatment) (n=32)
of people achieved 100% clearance with placebo
of people who were cleared after 12 weeks remained completely clear from all AK 1 year after the last PDT (n=50)2
87 people presenting with 4 to 8 mild-to-moderate AK spots on the face/forehead and/or scalp were treated with AMELUZ® or a placebo gel (a gel without medicine) and BF-RhodoLED® red light. Participants received a maximum of 2 PDT treatments and were examined 12 weeks and 1 year after the last treatment.1,3
RhodoLED® XL and BF-RhodoLED® are approved as interchangeable light sources.1
Most side effects occurred during illumination or shortly afterwards, were generally of mild or moderate intensity, and lasted for 1 to 4 days in most cases; in some cases they persisted for 1 to 2 weeks or even longer.
If you have any questions about AMELUZ®, please contact your health care provider.
If you have any questions about AMELUZ®, please contact your health care provider.
If you have any questions about AMELUZ®, please contact your health care provider.
INDICATION
AMELUZ® (aminolevulinic acid hydrochloride) topical gel, 10%, a porphyrin precursor, in combination with photodynamic therapy using BF-RhodoLED® or RhodoLED® XL lamp, is used for lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and scalp.
IMPORTANT SAFETY INFORMATION
Purpose: Photosensitizing agent
Uses: AMELUZ®, a porphyrin precursor, in combination with photodynamic therapy using BF-RhodoLED® or RhodoLED® XL lamp, is used for lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and scalp.
Warnings:
Do not use if you have a:
Ask your health care provider before use if you have:
When using this product:
Most common side effects at the application site are:
Most side effects occurred during illumination or shortly afterwards, were generally of mild or moderate intensity, and lasted for 1 to 4 days in most cases; in some cases they persisted for 1 to 2 weeks or even longer.
Pregnancy Warning: There is no available data on AMELUZ® use in pregnant women to inform a drug associated risk.
Lactation Warning: There is no available data regarding the presence of the active ingredient (aminolevulinic acid hydrochloride) in human milk, or the effects of aminolevulinic acid hydrochloride on the breastfed infant or on milk production.
Pediatric Warning: Safety and effectiveness in patients below the age of 18 has not been established.
Geriatric Warning: No overall differences in safety or effectiveness were observed between older (65 years and older) and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Directions:
Inactive ingredients: xanthan gum, soybean phosphatidylcholine, polysorbate 80, medium-chain triglycerides, isopropyl alcohol, dibasic sodium phosphate, monobasic sodium phosphate, sodium benzoate, and purified water.
References: 1. AMELUZ [prescribing information]. Woburn, MA: Biofrontera Inc; 2024. 2. Reinhold U. A review of BF-200 ALA for the photodynamic treatment of mild-to-moderate actinic keratosis. Future Oncol. 2017;13(27):2413-2428. 3. Reinhold U, Dirschka T, Ostendorf R, et al. A randomized, double-blind, phase III, multicentre study to evaluate the safety and efficacy of BF-200 ALA (Ameluz) vs placebo in the field-directed treatment of mild-to-moderate actinic keratosis with photodynamic therapy (PDT) when using the BF-RhodoLED lamp. Br J Dermatol. 2016;175(4):696-705. 4. Benov L. Photodynamic therapy: current status and future directions. Med Princ Pract. 2015;24(Suppl1):14-28.