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

NCT05662202 | Active Not Recruiting Phase 3 FDA Drug FDA Device

• 1 other identifier: ALA-AK-CT019
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Actinic Keratoses

Keywords

Actinic keratosis; Photodynamic therapy; 5-aminolevulinic acid; Photosensitizing Agents

Outcome Measures

Primary Outcomes (1)

• Overall subject complete response rate

  Percentage of subjects with all AK target lesions clinically cleared after last PDT

  12 weeks after the last PDT (Visit 4 or Visit 6)

Secondary Outcomes (17)

• 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)

Other Outcomes (8)

• Subject recurrence rate

  On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)

• Lesion recurrence rate

  On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)

• Recurrence rate of severe lesions

  On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)

Study Arms (2)

BF-200 ALA

EXPERIMENTAL

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

Vehicle

PLACEBO COMPARATOR

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

Interventions

BF-200 ALA and red light LED lamp COMBINATION_PRODUCT

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.

BF-200 ALA

Vehicle and red light LED lamp COMBINATION_PRODUCT

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.

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• All sexes, ≥ 18 years of age.
• Willingness to undergo a 2 mm punch biopsy for each (up to two) severe AK lesion ≥ 4 mm, if applicable, at the screening visit.
• Willingness and ability to comply with study procedures, particularly willingness to receive up to 2 PDTs within approximately 12 weeks.
• Subjects with good general health or with clinically stable medical conditions will be permitted to be included in the study.
• 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.
• Acceptance to abstain from extensive sunbathing and the use of a solarium or tanning beds during the treatment phase.
• For female subjects with reproductive potential: Negative serum pregnancy test.
• 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).

You may not qualify if:

• Any known history of hypersensitivity to ALA, porphyrins, or excipients of BF-200 ALA.
• History of soy or peanut allergy.
• 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.
• Clinically significant (cs) medical conditions making implementation of the protocol or interpretation of the study results difficult or impairing subject's safety such as:
• Presence of photodermatoses or porphyria
• Metastatic tumor or tumor with high probability of metastasis
• Infiltrating skin neoplasia (suspected or known)
• Unstable cardiovascular disease (New York Heart Association class III, IV)
• Unstable hematologic (including myelodysplastic syndrome), hepatic, renal, neurologic, or endocrine condition
• Unstable collagen-vascular condition
• Unstable gastrointestinal condition
• Immunosuppressive condition
• Presence of clinically significant inherited or acquired coagulation defect
• 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.
• Presence of strong artificial pigmentation (e.g., tattoos) or any other abnormality that may impact lesion assessment or light penetration in the treatment field.

Sponsors & Collaborators

• Biofrontera Inc.: lead

Study Sites (14)

Medical Dermatology Specialists

Phoenix, Arizona, 85006, United States

Location

Alliance Dermatology & Mohs Center

Phoenix, Arizona, 85032, United States

Location

Dermatology Practice

Greenwood Village, Colorado, 80111, United States

Location

Dermatology Associates PA of the Palm Beaches

Delray Beach, Florida, 33445, United States

Location

Gwinnett Clinical Research Center, Inc.

Snellville, Georgia, 30078, United States

Location

Laser and Skin Surgery Center of Indiana

Indianapolis, Indiana, 46260, United States

Location

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, 46168, United States

Location

DelRicht Research

Baton Rouge, Louisiana, 70809, United States

Location

Skin Search of Rochester, Inc.

Rochester, New York, 14623, United States

Location

Rochester Dermatologic Surgery

Victor, New York, 14564, United States

Location

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

Location

DermResearch, P.A.

Austin, Texas, 78759, United States

Location

Austin Institute for Clinical Research

Houston, Texas, 77056, United States

Location

Austin Institute for Clinical Research Inc.

Pflugerville, Texas, 78660, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

BF-200 ALA

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nathalie Zeitouni, MD

  Medical Dermatology Specialists; Phoenix, Arizona, United States

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 22, 2022
• Study Start: December 12, 2022
• Primary Completion: September 3, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (14)