Ameluz (aminolevulinic acid) / Biofrontera - LARVOL DELTA

Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Moderate to Severe Acne Vulgaris With Photodynamic Therapy in Adults (clinicaltrials.gov) - P2 | N=126 | Active, not recruiting | Sponsor: Biofrontera Bioscience GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Acne Vulgaris • Dermatology

Red-Light Photodynamic Therapy with 10% Aminolevulinic Acid (ALA) Following Microneedling in the Treatment of Facial Actinic Keratosis: Cosmetic and Clinical Outcomes. (PubMed, J Clin Aesthet Dermatol) - "We evaluated the cosmetic outcome and clearance of actinic keratoses (AKs) using photodynamic therapy (PDT) with microneedling-assisted delivery of 10% aminolevulinic acid (ALA) gel (Ameluz®, Biofrontera, Woburn, MA) with 30-minute incubation followed by 10-minute illumination with a red light (BF-RhodoLED®, 635nm, 37 J/cm2)...The study included a small number of subjects (N=5). Our results indicate that red light PDT using microneedling-assisted delivery of 10% ALA gel and a short 30-minute incubation is a safe and tolerable procedure producing good cosmetic outcomes in several skin quality parameters, such as texture and skin tone evenness, as well as an AK lesion clearance rate of 89.2 percent at Week 8, relatively low pain scores, and a reduced PDT treatment time."

Clinical data • Journal • Actinic Keratosis • Dermatology • Pain

A Non-randomized, Open-label, Multicenter Study to Evaluate the Safety and Tolerability of 10% Aminolevulinic Acid Gel in the Expanded Field-directed Treatment of Actinic Keratosis on the Face and Scalp with Red Light Photodynamic Therapy. (PubMed, J Clin Aesthet Dermatol) - "Although the allowed use of pain-reducing measures might have influenced evaluation of pain, it reflects how the procedure is managed in current practice. PDT with 10% ALA gel and red light illumination on an expanded treatment field was generally well tolerated."

Clinical • Journal • Actinic Keratosis • Dermatology • Pain

Biofrontera Inc. Reports Record Fiscal Year 2024 Financial Results and Provides a Business Update (GlobeNewswire) - "Reported record total revenues of $37.3 million for 2024, reflecting a 9.5% increase from $34.1 million in 2023 with Q4 2024 growing 18.5% over Q4 2023. The growth was primarily driven by increases in Ameluz sales volume and unit price...Total revenues for the fourth quarter of 2024 were $12.6 million, an increase of $2.0 million, or 18.5%, compared with $10.6 million for the fourth quarter of 2023. This growth reflects the continued adoption of Ameluz..."

Commercial • Basal Cell Carcinoma

Biofrontera Inc. Announces Completion of Patient Enrollment in Phase 3 Study of Ameluz (aminolevulinic acid HCI) Topical Gel, 10% for the Treatment of Actinic Keratoses on the Extremities, Neck and Trunk (GlobeNewswire) - "Biofrontera Inc...today announced the enrollment of the final patient in its Phase 3 clinical trial evaluating Ameluz (aminolevulinic acid hydrochloride) for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck and trunk...Expanding field treatment options for AKs beyond the face and scalp would address a critical unmet need in dermatology....With enrollment complete, Biofrontera anticipates finishing the treatment phase of the study by September, 2025 and the follow-up phase by Q2 2026. Pending positive outcomes, the company plans to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) in the second half of 2026."

Enrollment closed • FDA filing • Trial status • Actinic Keratosis

Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp (clinicaltrials.gov) - P3 | N=172 | Active, not recruiting | Sponsor: Biofrontera Bioscience GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Actinic Keratosis • Dermatology

Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Moderate to Severe Acne Vulgaris With Photodynamic Therapy in Adults (clinicaltrials.gov) - P2 | N=126 | Recruiting | Sponsor: Biofrontera Bioscience GmbH | Trial completion date: Feb 2025 ➔ Nov 2025 | Trial primary completion date: Feb 2025 ➔ Sep 2025

Trial completion date • Trial primary completion date • Acne Vulgaris • Dermatology

Biofrontera Inc. Announces Achievement of Key Milestone In Phase 3 Study Of Ameluz-Photodynamic Therapy (PDT) In The Treatment Of Superficial Basal Cell Carcinoma (sBCC) (GlobeNewswire) - "Last patient completed 1 year follow-up of study ALA-BCC-CT013 in December 2024; Data from follow-up will be included in FDA submission, expected in Q3 2025."

FDA filing • Trial status • Basal Cell Carcinoma

Cryotherapy in Combination with Red Light PDT for Actinic Keratosis of Full Face (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: Psoriasis Treatment Center of Central New Jersey

New P4 trial • Actinic Keratosis • Dermatology

Long-term follow-up of a randomized, double-blind, phase III, multi-centre study to evaluate the safety and efficacy of field-directed photodynamic therapy (PDT) of mild to moderate actinic keratosis using BF-200 ALA versus placebo and the BF-RhodoLED® lamp. (PubMed, J Eur Acad Dermatol Venereol) - P3 | "We showed that effectiveness of field-directed PDT with BF-200 ALA and narrow-spectrum red light was maintained during follow-up. Based on our results, field-directed PDT is a beneficial long-lasting treatment for AK patients."

Clinical • Journal • P3 data • Actinic Keratosis • Dermatology • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Long-term outcome of photodynamic therapy with hexyl aminolevulinate, 5-aminolevulinic acid nanoemulsion and methyl aminolevulinate for low-risk Basal Cell Carcinomas. (PubMed, Photodiagnosis Photodyn Ther) - "This trial shows that HAL has potential for dermatological PDT. However, the long-term efficacy of PDT in the treatment of low-risk BCCs remains rather low."

Journal • Basal Cell Carcinoma • Dermatology • Non-melanoma Skin Cancer • Oncology • Skin Nodular Basal Cell Carcinoma

A Case Report on the Successful Use of Daylight Photodynamic Therapy With BF-200 ALA Combined With Topical Terbinafine for the Treatment of Tinea Capitis Caused by Trichophyton rubrum in a Patient With Autoimmune Chronic Hepatitis. (PubMed, Photodermatol Photoimmunol Photomed) - No abstract available

Journal • Autoimmune Hepatitis • Dermatology • Hepatology • Immunology • Inflammation

Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp (clinicaltrials.gov) - P3 | N=165 | Recruiting | Sponsor: Biofrontera Bioscience GmbH | Trial completion date: Mar 2026 ➔ Jun 2026

Trial completion date • Actinic Keratosis • Dermatology

Biofrontera Inc. Announces Highly Significant Results In Phase 3 Study Of Ameluz-Photodynamic Therapy (PDT) Regarding The Treatment Of Superficial Basal Cell Carcinoma (sBCC) (GlobeNewswire) - P3 | N=186 | NCT03573401 | Sponsor: Biofrontera Bioscience GmbH | "Ameluz-PDT achieved 65.5% success (95/145 subjects) in this rigorous target, compared to 4.8% success (2/42 subjects) achieved with placebo-PDT (p<0.0001). Complete histological clearance was seen in 75.9% (110/145) of these lesions in the Ameluz arm, compared to 19.0% (8/42) with placebo. Complete clinical clearance was achieved in 83.4% (121/145) of patients treated with Ameluz compared to 21.4% (8/42) with placebo. The results for all other secondary efficacy parameters were equally highly significant (p<0.0001) with, for instance, 64.1% of Ameluz-PDT patients achieving total clearance of all sBCC lesions compared to only 4.8% of those treated with placebo-PDT....Once we finish the one-year follow up phase in December, we will be in a position to submit our dossier to the FDA around the end of Q2 / early Q3 of 2025."

FDA filing • P3 data: top line • Basal Cell Carcinoma

Biofrontera Inc. Announces Database Lock Of Phase 3 Study Of Ameluz-Photodynamic Therapy (PDT) In The Treatment Of Superficial Basal Cell Carcinoma (sBCC) (GlobeNewswire) - "Biofrontera Inc...announced today that the database for the treatment phase of study ALA-BCC-CT013 has been locked....The clinical data are now ready for final analysis....In addition to the final study report, the FDA requires the inclusion in the submission of follow-up data obtained 1 year after the first PDT. The last patient is expected to complete this follow up by December of this year, and submission is targeted for Q1 2025."

FDA filing • Trial status • Basal Cell Carcinoma • Oncology

FDA Approves Use of Up To Three Tubes of Biofrontera Inc.’s Ameluz (aminolevulinic acid HCI) Topical Gel, 10% In One Treatment (GlobeNewswire) - "Biofrontera Inc...announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s sNDA to increase the maximally approved dosage from one to three tubes of Ameluz per treatment....The sNDA was supported by two clinical Phase I safety studies in which three tubes of Ameluz were applied to 116 patients."

FDA approval • Actinic Keratosis

Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (SCCis) (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: The Center for Clinical and Cosmetic Research

New P2 trial • Bowens Disease • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Case Comprehensive Cancer Center | Recruiting ➔ Active, not recruiting

Enrollment closed • Actinic Keratosis • Dermatology • Pain

Efficacy of BF-200 ALA PDT with half- versus full-light dose in treating actinic keratosis with large field cancerization. (PubMed, Int J Dermatol) - No abstract available

Journal • Actinic Keratosis • Dermatology • Oncology

Duration of Ameluz Application in Acral Actinic Keratoses Response (clinicaltrials.gov) - P4 | N=28 | Terminated | Sponsor: Royal Cornwall Hospitals Trust | Dr Xie abroad on other research, current PI Dr John Frewen not at main centre, no other available PI identified. Study suspended.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Actinic Keratosis • Dermatology

Effective treatment of actinic keratosis on the hands with red light photodynamic therapy using BF-200 ALA. (PubMed, Photodiagnosis Photodyn Ther) - "This subgroup analysis indicates that PDT with BF-200 ALA provides a suitable treatment for AK lesions on the hands."

Journal • Actinic Keratosis • Dermatology • Pain

Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp (clinicaltrials.gov) - P3 | N=165 | Recruiting | Sponsor: Biofrontera Bioscience GmbH | Trial completion date: Apr 2025 ➔ Mar 2026 | Trial primary completion date: Jul 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • Actinic Keratosis • Dermatology

Long-Term Improvement of Different Types of Acne Vulgaris Using a Mild Photodynamic Therapy Protocol with BF-200 ALA Gel: A Series of Cases. (PubMed, J Clin Med) - "The good efficacy results were maintained over a follow-up period of 12.5 ± 10.8 months. In this study, we show that PDT with BF-200 ALA gel and low light dose is an effective and long-lasting option for the treatment of different acne types."

Journal • Acne Vulgaris • Dermatology

Home- vs clinic-based daylight photodynamic therapy with 5-aminolevulinic acid nanoemulsion (BF-200 ALA) for actinic keratosis: A randomized, single-blind, prospective study. (PubMed, Photodiagnosis Photodyn Ther) - "Self-performed home-based DL-PDT with BF-200 ALA gel is as effective as the one performed in a clinic-based setting, with a comparable safety profile, high levels of patient satisfaction and with advantages for the patients and their caregivers that can enhance patient´s adherence to the treatment."

Journal • Actinic Keratosis • Dermatology • Pain

Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT). (clinicaltrials.gov) - P3 | N=186 | Active, not recruiting | Sponsor: Biofrontera Bioscience GmbH | Trial primary completion date: Dec 2023 ➔ Mar 2024

Trial primary completion date • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology