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).

NCT03573401 | Active Not Recruiting Phase 3 Results FDA Drug FDA Device

• 1 other identifier: ALA-BCC-CT013
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 18

Brief Summary

The aim of this study is to test the safety and efficacy of photodynamic therapy (PDT) with the medication Ameluz® performed with the PDT-lamp BF-RhodoLED® in comparison to the respective placebo treatment for superficial basal cell carcinoma (BCC).

Conditions

Superficial Basal Cell Carcinoma

Keywords

ALA-PDT

Outcome Measures

Primary Outcomes (1)

• Composite Clinical and Histological Response of the Subject's Main Target Lesion as Assessed 12 Weeks After the Start of the Last PDT Cycle That Included Treatment of the Main Target Lesion.

  Each subject had one Main Target Lesion. The composite clinical and histological response rate of the subjects' Main Target Lesions is the percentage of subjects with a clinically and histologically cleared Main Target lesion 12 weeks after the start of the last PDT cycle that included treatment of the Main Target Lesion (Visit 5 or Visit 8).

  12 weeks after the start of the last PDT cycle that included treatment of the Main Target Lesion

Secondary Outcomes (13)

• Main Target Lesion Clinical Response Rate (According to Clinical Assessment Only) Assessed 12 Weeks After the Start of the Last PDT Cycle

  12 weeks after the start of the last PDT cycle

• Main Target Lesion Histological Response Rate (According to Histological Assessment Only) Assessed 12 Weeks After the Start of the Last PDT Cycle

  12 weeks after the start of the last PDT cycle

• Subject Complete Clinical Response (Complete Clearance of All Target Lesions According to Clinical Assessment Only) Assessed 12 Weeks After the Start of the Last PDT Cycle.

  12 weeks after the start of the last PDT cycle

• Subject Complete Response (Clinically and Histologically Cleared Main Target Lesion (See Above) and Complete Clinical Remission of All Additional Target Lesions) Assessed 12 Weeks After the Start of the Last PDT Cycle.

  12 weeks after the start of the last PDT cycle

• Lesion Complete Clinical Response Rate Per Treatment Arm (Complete Clearance of Individual Lesions (Main and Additional Target Lesions)) According to Clinical Assessment Only, Assessed 12 Weeks After the Start of the Last PDT Cycle.

  12 weeks after the start of the last PDT cycle

Study Arms (2)

BF-200 ALA

EXPERIMENTAL

Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). Photodynamic therapy (PDT)

Combination Product: Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)

Vehicle

PLACEBO COMPARATOR

Topical application of vehicle to BF-200 ALA containing no active ingredient. Photodynamic therapy (PDT)

Combination Product: Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)

Interventions

Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) COMBINATION_PRODUCT

The Main Target Lesion will be marked by at least 3 ink marks prior to PDT to enable precise excision for histopathological assessment 12 weeks after the first or second PDT cycle dependent on the clearance status of the lesion. All target lesions should be prepared prior to drug application by degreasing, removal of all scabs and crusts, and roughening of the surface, if appropriate. Bleeding should be avoided. The formulations will then be applied to the lesions (maximal combined lesion area incl. margin is 20 cm²) located in 1 to 2 illumination areas. The medication should be applied to the entire lesion(s) plus a 0.5 - 1.0 cm margin surrounding each lesion at a thickness of 1 mm, allowed to dry (for approximately 10 minutes), covered with occlusive dressing, and incubated for approximately 3 h. Thereafter, any remnants of the IMP will be removed carefully and the PDT illumination will be administered using the light emitting diode (LED) red light device BF-RhodoLED®.

Also known as: ALA-PDT, Ameluz®-PDT

BF-200 ALA

Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient) COMBINATION_PRODUCT

The Main Target Lesion will be marked by at least 3 ink marks prior to PDT to enable precise excision for histopathological assessment 12 weeks after the first or second PDT cycle dependent on the clearance status of the lesion. All target lesions should be prepared prior to drug application by degreasing, removal of all scabs and crusts, and roughening of the surface, if appropriate. Bleeding should be avoided. The formulations will then be applied to the lesions (maximal combined lesion area incl. margin is 20 cm²) located in 1 to 2 illumination areas. The medication should be applied to the entire lesion(s) plus a 0.5 - 1.0 cm margin surrounding each lesion at a thickness of 1 mm, allowed to dry (for approximately 10 minutes), covered with occlusive dressing, and incubated for approximately 3 h. Thereafter, any remnants of the IMP will be removed carefully and the PDT illumination will be administered using the light emitting diode (LED) red light device BF-RhodoLED®.

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 to sign the informed consent form and Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent form and a HIPAA form must be obtained in writing for all subjects prior to starting any study procedures.
• Men or women ≥18 years of age.
• Presence of ≥1 naïve sBCC lesion in the treatment areas face/forehead, bald scalp, extremities and/or neck/trunk, all of which are, according to the clinical judgement of the investigator, likely to be histologically confirmed as sBCCs. Lesions should not be within the embryonic fusion planes (H-zone), especially within 2 cm of the hair zone or on the ears. In case of multiple lesions, one lesion is defined as Main Target Lesion which will be excised at the end of the clinical observation period. Only eligible naïve sBCCs, confirmed by histology taken at screening, are allowed to be included in the study as Main or Additional Target Lesions. Thus, eligible sBCCs must lack any histological evidence of aggressive growth patterns (e.g. severe squamous metaplasia, infiltrative/desmoplastic features or basosquamous features). BCCs assessed as non-naïve (e.g. previously treated or recurrent) or non-eligible by biopsy taken at screening (and in a distance \>5 cm from the next lesion included in the study) should be excised by surgery or removed by cryotherapy in a timely manner. Other treatments for these lesions are not allowed during the study.
• The diameter of each eligible lesion should be ≥ 0.6 cm, and the entire treatment field must not exceed \~20 cm². The treatment field is defined as the field to which IMP is applied, usually including the target lesions and margins surrounding the lesions of up to 1 cm. For the Main Target Lesion, the maximal lesion size should be such that surgical excision without a skin transplant is feasible according to the investigator's judgement.
• Target BCC lesions must be discrete and located within 1-2 illumination areas (the illumination area is defined by the effective illumination area of the BF-RhodoLED® device with approximately 6 x 16 cm).
• Willingness to receive up to 4 PDTs within 3.5 months and excision of the Main Target Lesion either at Visit 5, if clinically cleared, or at the end of the clinical observation period 12 weeks after the start of the last PDT cycle (Visit 8), irrespective of whether the treated Main Target Lesion was clinically cleared or not.
• Free of significant physical abnormalities (e.g. tattoos, dermatoses) within the potential treatment field plus a 5 cm radius surrounding the target lesion(s) as they may interfere with examination or final evaluation.
• Willingness to stop the use of moisturizers and any other cosmetics within the treatment field plus a 5 cm radius surrounding the target lesion(s) 48 hours prior to an office visit and 48 hours after each PDT session. Sunscreen will be allowed, but should not be applied to the treatment field plus the 5 cm radius surrounding the target lesion(s) within approximately 24 h prior to a clinical visit.
• Acceptance to abstain from extensive sunbathing and the use of a solarium during the clinical observation period. Subjects with sunburn within treatment areas cannot be included until fully recovered.
• Healthy subjects and subjects with clinically stable medical conditions, including, but not limited to controlled hypertension, diabetes mellitus type II, hypercholesterolemia, and osteoarthritis, will be permitted to be included in the study if their medication is not prohibited by this protocol.
• Women of childbearing potential are permitted to participate in this study only if they have a negative serum pregnancy test at screening and are willing to use a highly effective method of contraception during the clinical observation period of the study.

You may not qualify if:

• History of hypersensitivity to 5-ALA or any ingredient of BF-200 ALA which includes soybean phosphatidylcholine.
• Hypersensitivity to porphyrins.
• Current treatment with immunosuppression therapy.
• Presence of photodermatoses.
• Presence of porphyria.
• Presence of clinically significant inherited or acquired coagulation defect.
• Evidence of clinically significant (CS) unstable medical conditions, such as:
• Metastatic tumor or tumor with high probability of metastasis.
• Cardiovascular disease class III, IV (New York Heart Association \[NYHA\]).
• Immunosuppressive condition.
• Hematologic, hepatic, renal, neurologic, or endocrine condition.
• Collagen-vascular condition.
• Gastrointestinal condition.
• Clinically relevant cardiovascular, hepatic, renal, neurologic, endocrine, or other major systemic diseases that complicate implementation of the protocol or interpretation of the study results.
• Gorlin Syndrome or Xeroderma pigmentosum.

Sponsors & Collaborators

• Biofrontera Inc.: lead

Study Sites (18)

Medical Dermatology Specialists

Phoenix, Arizona, 85006, United States

Location

Alliance Dermatology & Mohs Center

Phoenix, Arizona, 85032, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Cosmetic Laser Dermatology

San Diego, California, 92121, United States

Location

AboutSkin Research, LLC

Greenwood Village, Colorado, 80111, United States

Location

Dermatology Associates PA of the Palm Beaches

Delray Beach, Florida, 33445, United States

Location

University of Florida Dept of Dermatology

Gainesville, Florida, 32606, United States

Location

Laser and Skin Surgery Center of Indiana

Indianapolis, Indiana, 46260, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

The Narrows Institute for Biomedical Research and Education, Inc.

Brooklyn, New York, 11209, 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

Austin Institute for Clinical Research Inc.

Houston, Texas, 77056, United States

Location

Austin Institute for Clinical Research Inc.

Pflugerville, Texas, 78660, United States

Location

Jordan Valley Dermatology

West Jordan, Utah, 84088, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Interventions

Photochemotherapy; 1-phenyl-3,3-dimethyltriazene

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Results Point of Contact

• Title: Clinical Trial Management
• Organization: Biofrontera Discovery GmbH

ctm@bfinc.com

Not available

Study Officials

• David M. Pariser, MD

  Virginia Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: June 19, 2018
• First Posted: June 29, 2018
• Study Start: September 25, 2018
• Primary Completion: March 19, 2024
• Study Completion (Estimated): February 1, 2029
• Last Updated: January 14, 2026
• Results First Posted: April 29, 2025

Record last verified: 2025-12

Locations

US (18)