(N=55)
of patients were 100% cleared after 12 weeks‡
(12 weeks after the last treatment) (N=32)
of patients achieved 100% clearance with placebo‡
of patients who were cleared after 12 weeks remained completely clear from all AK one year after the last PDT (n=50)2
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.
PDT is a non-invasive skin treatment managed by your dermatologist. It uses a gel that works with an LED light.1,4
AMELUZ® is a topical gel used in combination with the BF-RhodoLED® red light for PDT, for the treatment of mild-to-moderate actinic keratosis on the face and scalp.1
BF-RhodoLED® is an LED lamp that emits a deep-penetrating red light which activates the PDT treatment.1,5
If you have any questions about AMELUZ®, we would like to hear from you!
Call us at 1‑844‑4AMELUZ (1‑844‑426‑3589)
Or email us at info@bfinc.com
(N=55)
of patients were 100% cleared after 12 weeks‡
(12 weeks after the last treatment) (N=32)
of patients achieved 100% clearance with placebo‡
of patients who were cleared after 12 weeks remained completely clear from all AK one year after the last PDT (n=50)2
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.
PDT is a non-invasive skin treatment managed by your dermatologist. It uses a gel that works with an LED light.1,4
AMELUZ® is a topical gel used in combination with the BF-RhodoLED® red light for PDT, for the treatment of mild-to-moderate actinic keratosis on the face and scalp.1
BF-RhodoLED® is an LED lamp that emits a deep-penetrating red light which activates the PDT treatment.1,5
AMELUZ® penetrates the epidermis (top layer) of your skin to reach the premalignant cells that cause AK. Its active ingredient is then converted into the light-activated agent called PpIX. The red light of BF-RhodoLED® illuminates these cells and activates the agent, setting off a reaction that destroys premalignant cells that cause AK—while leaving healthy skin cells mostly intact.1,2,6
If you have any questions about AMELUZ®, we would like to hear from you!
Call us at 1‑844‑4AMELUZ (1‑844‑426‑3589)
Or email us at info@bfinc.com
(N=55)
of patients were 100% cleared after 12 weeks‡
(12 weeks after the last treatment) (N=32)
of patients achieved 100% clearance with placebo‡
of patients who were cleared after 12 weeks remained completely clear from all AK one year after the last PDT (n=50)2
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.
PDT is a non-invasive skin treatment managed by your dermatologist. It uses a gel that works with an LED light.1,4
AMELUZ® is a topical gel used in combination with the BF-RhodoLED® red light for PDT, for the treatment of mild-to-moderate actinic keratosis on the face and scalp.1
BF-RhodoLED® is an LED lamp that emits a deep-penetrating red light which activates the PDT treatment.1,5
AMELUZ® penetrates the epidermis (top layer) of your skin to reach the premalignant cells that cause AK. Its active ingredient is then converted into the light-activated agent called PpIX. The red light of BF-RhodoLED® illuminates these cells and activates the agent, setting off a reaction that destroys premalignant cells that cause AK—while leaving healthy skin cells mostly intact.1,2,6
If you have any questions about AMELUZ®, we would like to hear from you!
Call us at 1‑844‑4AMELUZ (1‑844‑426‑3589)
Or email us at info@bfinc.com
INDICATION
AMELUZ® (aminolevulinic acid hydrochloride) topical gel, 10%, a porphyrin precursor, in combination with photodynamic therapy using BF-RhodoLED®* lamp, is indicated for the lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and scalp.
IMPORTANT SAFETY INFORMATION
AMELUZ® (aminolevulinic acid hydrochloride), topical gel, 10%
Purpose: Photosensitizing agent
Uses: AMELUZ® gel, a porphyrin precursor, in combination with photodynamic therapy using BF-RhodoLED® 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 were:
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 pediatric 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, propylene glycol, sodium benzoate and purified water.
Other Information:
*AMELUZ® is also approved in combination with PDT using RhodoLED® XL lamp, which is currently not available for commercial utilization.
References: 1. AMELUZ [prescribing information]. Woburn, MA: Biofrontera Inc; 2023. 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(Suppl 1):14-28. 5. Agostinis P, Berg K, Cengel KA, et al. Photodynamic therapy of cancer: an update. CA Cancer J Clin. 2011;61(4):250-281. 6. Maisch T, Santarelli F, Schreml S, et al. Fluorescence induction of protoporphyrin IX by a new 5-aminolevulinic acid nanoemulsion used for photodynamic therapy in a full-thickness ex vivo skin model. Exp Dermatol. 2010;19(8):e302-305.