A 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

Plain English Summary

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 is a Phase 3 clinical trial sponsored by Biofrontera Inc. studying Actinic Keratoses. Tests the safety, tolerability, and efficacy of BF-200 ALA (Ameluz®) combined with red light LED lamp for treating Actinic Keratosis on extremities and neck/trunk. For patients with 4-15 mild to moderate Actinic Keratosis lesions, willing to undergo up to 2 PDT treatments within 12 weeks. Participation involves applying BF-200 ALA gel and red light LED lamp treatments, with follow-ups to assess lesion clearance. Alternatives include other topical treatments or surgical removal of lesions. The trial aims to enroll 172 participants.

Official Summary

The aim of this study is to test the safety. tolerability and efficacy of field-directed photodynamic therapy (PDT) with 10% aminolevulinic acid gel (Ameluz®, BF-200 ALA) in combination with one of the narrow spectrum red light RhodoLED lamps in comparison to vehicle treatment for actinic keratosis (AK) on the extremities and neck/trunk.

Who Can Participate

Here is what you need to know about eligibility for this trial. Eligible if 18 years or older, willing to provide informed consent, and has 4-15 Actinic Keratosis lesions. Not eligible if history of ALA or porphyrin allergy, severe medical conditions, or recent use of other treatments. Age: 18 years or older. Health: Good general health or clinically stable medical conditions. This trial is studying Actinic Keratoses, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures the overall subject complete response rate, which means the percentage of patients with all lesions cleared after the last PDT treatment. The specific primary outcome measures are: Overall subject complete response rate (12 weeks after the last PDT (Visit 4 or Visit 6)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses the treatment gap for Actinic Keratosis, a common skin condition, by evaluating a new combination therapy. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Actinic Keratoses, where improved treatment options are needed.

Investor Insight

Market size is significant, with a large patient population and limited effective treatments currently available. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor about your eligibility and the potential benefits and risks of participating. Participation involves applying BF-200 ALA gel and red light LED lamp treatments, with follow-ups to assess lesion clearance. The trial is being conducted at 14 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 172 participants

Interventions

• 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
• 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.

Primary Outcomes

• Overall subject complete response rate (12 weeks after the last PDT (Visit 4 or Visit 6))

Secondary Outcomes

• Overall subject complete response rate for subjects with lesions treated on extremities (12 weeks after the last PDT (Visit 4 or Visit 6))
• Overall subject complete response rate for subjects with lesions treated on neck/trunk (12 weeks after the last PDT (Visit 4 or Visit 6))
• Lesion complete response rate (12 weeks after the last PDT (Visit 4 or Visit 6))
• Complete response rate for severe lesions (12 weeks after the last PDT (Visit 4 or Visit 6))
• Subject complete response rate after PDT-1 (12 weeks after PDT-1 (Visit 4))

Full Eligibility Criteria

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 

Trial Locations

• Medical Dermatology Specialists, Phoenix, Arizona, United States
• Alliance Dermatology & Mohs Center, Phoenix, Arizona, United States
• Dermatology Practice, Greenwood Village, Colorado, United States
• Dermatology Associates PA of the Palm Beaches, Delray Beach, Florida, United States
• Gwinnett Clinical Research Center, Inc., Snellville, Georgia, United States
• Laser and Skin Surgery Center of Indiana, Indianapolis, Indiana, United States
• The Indiana Clinical Trials Center, PC, Plainfield, Indiana, United States
• DelRicht Research, Baton Rouge, Louisiana, United States
• Skin Search of Rochester, Inc., Rochester, New York, United States
• Rochester Dermatologic Surgery, Victor, New York, United States
• ...and 4 more locations

Frequently Asked Questions

Related Conditions

• Actinic Keratosis
• Photodynamic Therapy
• Skin Cancer Prevention
• Photodermatoses
• Porphyria
• Basal Cell Carcinoma
• Squamous Cell Carcinoma
• Skin Lesion Removal
• Dermatological Treatments
• Phototherapy

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