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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified March 2026 by Biofrontera Inc.
Sponsor
Biofrontera Inc.
Information Provided by (Responsible Party)
Biofrontera Inc.
Clinicaltrials.gov Identifier
NCT05662202
Other Study ID Numbers:
ALA-AK-CT019
First Submitted
November 28, 2022
First Posted
December 21, 2022
Last Update Posted
April 2, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Actinic Keratoses
Combination Product: BF-200 ALA and red light LED lampCombination Product: Vehicle and red light LED lamp

Study Design

Study TypeInterventional
Actual Enrollment172 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA Randomized, Double-blind, Vehicle-controlled, Multicenter Phase III Study to Evaluate the Safety, Tolerability, and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using the BF-RhodoLED® XL or BF-RhodoLED® Lamp
Study Start DateDecember 11, 2022
Actual Primary Completion DateSeptember 2, 2025
Actual Study Completion Date1mo 1w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
BF-200 ALA
Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). Red light photodynamic therapy (PDT)
Combination Product: BF-200 ALA and red light LED lamp
Up to two PDTs using a RhodoLED lamp (RhodoLED® XL or BF-RhodoLED®) (ALA-PDT, Ameluz®-PDT): Topical application of up to 3 tubes BF-200 ALA on the expanded treatment field (up to 240 cm²), followed by red light illumination with a RhodoLED lamp after 3 h incubation of study medication under occlusive dressing. PDT-1 will be performed at Visit 2. Clinical clearance will be assessed 12 weeks after PDT-1 (Visit 4). In case of remaining lesions at Visit 4, PDT-2 will be performed at the same visit.
Vehicle
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
Combination Product: Vehicle and red light LED lamp
Up to two PDTs using a RhodoLED lamp (RhodoLED® XL or BF-RhodoLED®) (Vehicle-PDT): Topical application of up to 3 tubes vehicle on the expanded treatment field (up to 240 cm²), followed by red light illumination with a RhodoLED lamp after 3 h incubation of study medication under occlusive dressing. PDT-1 will be performed at Visit 2. Clinical clearance will be assessed 12 weeks after PDT-1 (Visit 4). In case of remaining lesions at Visit 4, PDT-2 will be performed at the same visit.

Outcome Measures

Primary Outcome Measures
  1. Overall subject complete response rate
    Percentage of subjects with all AK target lesions clinically cleared after last PDT
Secondary Outcome Measures
  1. Overall subject complete response rate for subjects with lesions treated on extremities
    Percentage of subjects with all AK target lesions on extremities clinically cleared after last PDT
  2. Overall subject complete response rate for subjects with lesions treated on neck/trunk
    Percentage of subjects with all AK target lesions on neck/trunk clinically cleared after last PDT
  3. Lesion complete response rate
    Percentage of clinically cleared individual AK target lesions in relation to total number of AK target lesions at baseline (Visit 2) after the last PDT, overall and stratified by treatment area and AK severity at baseline (according to Olsen)
  4. Complete response rate for severe lesions
    Percentage of clinically cleared individual severe AK lesions in relation to total number of severe AK lesions at baseline (according to Olsen; Visit 2) after the last PDT, overall and stratified by treatment area
  5. Subject complete response rate after PDT-1
    Percentage of subjects with all AK target lesions clinically cleared after PDT-1, overall and stratified by AK baseline parameters
  6. Lesion complete response rate after PDT-1
    Percentage of clinically cleared individual AK target lesions in relation to total number of AK target lesions at baseline (Visit 2) after PDT-1, overall and stratified by treatment area and AK severity at baseline (according to Olsen \[mild, moderate, severe\])
  7. Complete response rate for severe lesions after PDT-1
    Percentage of clinically cleared individual severe AK lesions in relation to total number of severe AK lesions at baseline (according to Olsen \[mild, moderate, severe\]; Visit 2) after PDT-1, overall and stratified by treatment area
  8. Esthetic appearance at the end of treatment phase assessed by the investigator
    The esthetic appearance after the last PDT as assessed by the investigator as assessed by the subject according to a 4-point scale ranging from 0 (=very good) to 3 (=unsatisfactory); overall and stratified by treatment area
  9. Esthetic outcome at the end of treatment phase assessed by the subject
    The esthetic outcome after the last PDT as assessed by the subject according to a 4-point scale ranging from 0 (=very good) to 3 (=unsatisfactory); overall and stratified by treatment area
  10. Satisfaction with PDT at the end of treatment phase
    Satisfaction with PDT treatment after the last PDT as assessed by the subject via questionnaire, 1. if they would chose PDT treatment in the future in case of recurrence or similar disease (yes/no) and 2. how they would rate the PDT treatment in comparison to other treatment modalities, if applicable (better than/ similar/ worse). The treatment modalities should be documented, if applicable); overall and stratified by treatment area
  11. Frequency and extent of adverse events (AEs), AEs of Special Interest (AESIs), serious AEs (SAEs) and treatment-emergent AEs (TEAEs) during treatment phase
    Frequency and extent of AEs, AESIs, SAEs, and TEAEs, overall and stratified by demographics, skin type class (I-III and IV-VI), size of the treatment field, and treatment area. TEAEs (including application site skin reactions and discomfort) are defined as all AEs with onset or worsening after treatment with IMP.
  12. New lesions inside the treatment field during treatment phase
    New lesions: AK, non-melanoma skin cancer \[NMSC, including Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC) or Bowen's Disease (BD)\] or melanoma
  13. Assessment of application site reactions
    Application site reactions (bleeding, burning, discharge, edema, erosion, erythema, exfoliation, hyperalgesia, induration, irritation, paraesthesia, pruritus, pustules, scabbing, or vesicles) will be assessed on a 4-point scale: grade 0 = none, grade 1 = mild, grade 2 = moderate, grade 3 = severe.
  14. Application site pain during illumination
    Reported by the subjects assessed on an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain); overall and stratified by size of the treatment field and treatment area
  15. Number of patients with significant changes of vital signs
    Number of patients with changes in blood pressure (systolic and diastolic) \[mmHg\] and changes in pulse rate \[beats/min\]. Findings which differ from reference range and are considered to be clinically significant are to be reported.
  16. Number of patients with significant changes in safety laboratory
    Changes in clinical chemistry, in hematology and urinalysis parameters as defined in the protocol. Findings which differ from reference range and are considered to be clinically significant are to be reported.
  17. Number of patients with abnormal findings in physical examination
    Physical examination of head, neck, skin, lymph nodes, thorax including heart and lungs, abdomen, and musculoskeletal, peripheral vascular and nervous system status will be performed. Abnormal findings, considered to be clinically significant, are to be reported.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
1. Willingness and ability of subjects to provide informed consent and sign the Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent and HIPAA form must be obtained in writing prior to starting any study procedures. 2. 4 - 15 mild to moderate clinically confirmed AK lesions according to Olsen either on the extremities or on the neck/trunk with a diameter of ≥ 4 mm that must be present in the treatment field (defined as AK target lesions). In addition, non-target AK lesions may be present in the treatment field, including up to two severe AK lesions ≥ 4 mm. For each severe AK lesion (≥ 4 mm), a biopsy must be taken for confirmation of diagnosis. The treatment field (continuous or in several patches) totaling approx. either 80 cm², 160 cm² or 240 cm2 must be within one effective illumination area of the BF-RhodoLED® XL but may require up to three illuminations with the BF-RhodoLED®. All AK target lesions and, if applicable, severe AK lesions ≥ 4 mm located in the treatment field should be clearly distinguishable, without restrictions on the distance between lesions, and should have a minimal distance of 1 cm to the border of the treatment field. 3. All sexes, ≥ 18 years of age. 4. Willingness to undergo a 2 mm punch biopsy for each (up to two) severe AK lesion ≥ 4 mm, if applicable, at the screening visit. 5. Willingness and ability to comply with study procedures, particularly willingness to receive up to 2 PDTs within approximately 12 weeks. 6. Subjects with good general health or with clinically stable medical conditions will be permitted to be included in the study. 7. Willingness to stop the use of moisturizers and any other non-medical topical treatments within the treatment field at least 24 h prior to the next clinical visit. 8. Acceptance to abstain from extensive sunbathing and the use of a solarium or tanning beds during the treatment phase. 9. For female subjects with reproductive potential: Negative serum pregnancy test. 10. For female subjects with reproductive potential: Effective contraception at screening visit and throughout the treatment phase of the study (until Visit 4 or Visit 6).
Exclusion Criteria
1. Any known history of hypersensitivity to ALA, porphyrins, or excipients of BF-200 ALA. 2. History of soy or peanut allergy. 3. Sunburn or other possible confounding skin conditions (e.g., wounds, irritations, bleeding, or skin infections) inside or in close proximity (\< 2 cm distance) to the treatment field. 4. Clinically significant (cs) medical conditions making implementation of the protocol or interpretation of the study results difficult or impairing subject's safety such as: 1. Presence of photodermatoses or porphyria 2. Metastatic tumor or tumor with high probability of metastasis 3. Infiltrating skin neoplasia (suspected or known) 4. Unstable cardiovascular disease (New York Heart Association class III, IV) 5. Unstable hematologic (including myelodysplastic syndrome), hepatic, renal, neurologic, or endocrine condition 6. Unstable collagen-vascular condition 7. Unstable gastrointestinal condition 8. Immunosuppressive condition 9. Presence of clinically significant inherited or acquired coagulation defect 5. Clinical diagnosis of atopic dermatitis, Bowen´s disease (BD), basal cell carcinoma (BCC), eczema, psoriasis, rosacea, squamous cell carcinoma (SCC), other malignant or benign tumors inside or in close proximity (\< 2 cm distance) to the treatment field. 6. Presence of strong artificial pigmentation (e.g., tattoos) or any other abnormality that may impact lesion assessment or light penetration in the treatment field. 7. Any physical therapy such as cryotherapy, laser therapy, electrodessication, microdermabrasion, surgical removal of lesions, curettage, or treatment with chemical peels such as trichloroacetic acid inside or in close proximity (\< 10 cm distance) to the treatment field within 4 weeks prior to screening. 8. Any of the topical treatments defined below within the designated periods prior to screening: 1. Topical treatment with ALA or ALA esters (e.g., methyl aminolevulinic acid (MAL)) inside the treatment field within 3 months. 2. Topical treatment with immunomodulatory, cytostatic, or cytotoxic drugs inside or in close proximity (\< 10 cm distance) to the treatment field within 3 months. 3. Start of topical administration of a medication with hypericin or other drugs with phototoxic or photoallergic potential inside or in close proximity (\< 10 cm distance) to the treatment field within 4 weeks. Subjects may, however, be eligible if such medication was applied for more than 4 weeks prior to screening without evidence of an actual phototoxic/photoallergic reaction. 9. Any use of the systemic treatments within the designated periods prior to screening: 1. Cytostatic or cytotoxic drugs within 6 months. 2. Immunosuppressive therapies or ALA or ALA esters (e.g., MAL) within 12 weeks. 3. Drugs known to have major organ toxicity within 8 weeks. 4. Interferon or glucocorticosteroids within 6 weeks. 5. Start of intake of medication with hypericin or drugs with phototoxic or photoallergic potential within 8 weeks prior to screening. Subjects may, however, be eligible if such medication was taken in for more than 8 weeks prior to the screening visit without evidence of an actual phototoxic/photoallergic reaction. 10. Breast feeding women. 11. Suspicion of drug or alcohol abuse. 12. Subjects unlikely to comply with protocol, e.g., inability to return for visits, unlikely to complete the study, or inappropriate in the opinion of the investigator. 13. A member of study site staff or sponsor staff directly involved in the conduct of the protocol or a close relative thereof. 14. Receipt of any investigational drug or medical product within 8 weeks before screening or simultaneous participation in another clinical study. Reassessment of subjects is allowed once in case exclusion criterion 3 is met and eligibility can be achieved within 4 weeks. Reassessment can be done on the day of the actual treatment. Dosing day exclusion criteria: At Visit 2 (baseline, PDT-1) Subjects with sunburn or other possibly confounding skin conditions (e.g., wounds, irritations, bleeding, or skin infections) inside or in close proximity (\< 2 cm distance) to the treatment field. Reassessment of subjects is allowed once if the sunburn or other confounding skin conditions is/are expected to resolve within 2 weeks. At Visit 4 (PDT-2) Subjects with sunburn or other possibly confounding skin conditions (e.g., wounds, irritations, bleeding, or skin infections) inside or in close proximity (\< 2 cm distance) to the treatment field. Rescheduling of PDT-2 can be performed once at the earliest possibility after resolution, but rescheduling should not exceed 2 weeks.

Contacts and Locations

Sponsors and CollaboratorsBiofrontera Inc.
Locations
Medical Dermatology Specialists | Phoenix Arizona, United States, 85006Alliance Dermatology & Mohs Center | Phoenix Arizona, United States, 85032Dermatology Practice | Greenwood Village Colorado, United States, 80111Dermatology Associates PA of the Palm Beaches | Delray Beach Florida, United States, 33445Gwinnett Clinical Research Center, Inc. | Snellville Georgia, United States, 30078Laser and Skin Surgery Center of Indiana | Indianapolis Indiana, United States, 46260The Indiana Clinical Trials Center, PC | Plainfield Indiana, United States, 46168DelRicht Research | Baton Rouge Louisiana, United States, 70809Skin Search of Rochester, Inc. | Rochester New York, United States, 14623Rochester Dermatologic Surgery | Victor New York, United States, 14564Clinical Research Center of the Carolinas | Charleston South Carolina, United States, 29407DermResearch, P.A. | Austin Texas, United States, 78759Austin Institute for Clinical Research | Houston Texas, United States, 77056Austin Institute for Clinical Research Inc. | Pflugerville Texas, United States, 78660
Investigators
Principal Investigator: Nathalie Zeitouni, MD, Medical Dermatology Specialists; Phoenix, Arizona, United States