Superficial Basal Cell CarcinomaPhase 3NCT03573401
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).
A Phase 3 study testing Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) in people with Superficial Basal Cell Carcinoma, run by Biofrontera Inc. at 18 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Basal Cell Carcinoma
- What is being tested?
- Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 18 sitesUnited States
- Study dates
- 25 Sep 2018to Feb 2029
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 33Show fewer
- 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.
- Presence and/or physical treatment of skin tumors other than (naïve) sBCC (e.g. malignant melanoma, squamous cell carcinoma (SCC), Bowen's disease, aggressive BCC or nBCC diagnosed at the screening visit by clinical assessment) within a distance of ≤ 5 cm from the nearest target lesion within 4 weeks prior to PDT (Visit 2) until the end of the clinical observation period. However, biopsied lesion(s) that were not confirmed eligible at screening and which are located at a distance of > 5 cm from any lesion(s) that will be included in the study can be surgically removed. Treatment by PDT or topical medication during the course of the clinical observation period of the study triggers exclusion of the subject.
- If lesion(s) are assessed as non-eligible by biopsy during initial screening and these lesions are localized within a distance of 5 cm from an otherwise suitable lesion, this suitable lesion must be excluded from the study.
- Αny AK lesions within the treatment field (lesion area including margin of 0.5 to 1.0 cm).
- Any topical medical treatment of AK, other non-melanoma skin cancers (NMSC), or melanoma (except for IMP treatment of the target lesion(s)) starting 12 weeks prior to Visit 2 (PDT-1) and lasting until the end of the clinical observation period.
- Any other topical medical treatment of the skin 12 weeks prior to Visit 2 (PDT-1) until the end of the clinical observation period, with the exception of:
- Topical treatments with corticosteroids (allowed throughout the clinical observation period of the study).
- Topical non-steroidal anti-inflammatory drugs (NSAIDs such as diclofenac) (allowed throughout the clinical observation period of the study with the restriction of 7 days prior to and 7 days after PDTs).
- Start of intake of medication with hypericin or systemically acting drugs with phototoxic or photoallergic potential within 8 weeks prior to screening.
- Any of the systemic treatments listed below, within the designated period prior to PDT and during the clinical observation period.
- Interferon - 6 weeks
- Immunomodulators or immunosuppressive therapies - 12 weeks
- Cytotoxic drugs - 6 months
- Investigational drugs - 8 weeks
- Drugs known to have major organ toxicity - 8 weeks
- Corticosteroids (oral or injectable) - 6 weeks
- MAL or ALA - 12 weeks
- Systemic treatment with NSAIDs is not to be used 7 days prior to and 7 days after PDT. ASA (e.g. Aspirin®) up to 100 mg/ day, ibuprofen up to 200 mg/ day, and acetaminophen (e.g. Tylenol®) is allowed during this period.
- Presence of tattoos, skin inflammation, wounds, etc. in the treatment field(s) plus a 5 cm radius surrounding the target lesion(s).
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
The Narrows Institute for Biomedical Research and Education, Inc.
Brooklyn, New York, 11209
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
Dermatology Associates PA of the Palm Beaches
Delray Beach, Florida, 33445
Henry Ford Health System
Detroit, Michigan, 48202
First OC Dermatology
Fountain Valley, California, 92708
University of Florida Dept of Dermatology
Gainesville, Florida, 32606
AboutSkin Research, LLC
Greenwood Village, Colorado, 80111
Austin Institute for Clinical Research Inc.
Houston, Texas, 77056
Laser and Skin Surgery Center of Indiana
Indianapolis, Indiana, 46260
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
Austin Institute for Clinical Research Inc.
Pflugerville, Texas, 78660
Medical Dermatology Specialists
Phoenix, Arizona, 85006
Alliance Dermatology & Mohs Center
Phoenix, Arizona, 85032
Skin Search of Rochester, Inc
Rochester, New York, 14623
Cosmetic Laser Dermatology
San Diego, California, 92121
Rochester Dermatologic Surgery
Victor, New York, 14564
Jordan Valley Dermatology
West Jordan, Utah, 84088
About this study
Official title: A Randomized, Double Blind, Vehicle-controlled Multicenter Phase III 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).
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).
Read the detailed description
The study will be conducted as randomized, double blind and vehicle-controlled ( 4:1 ratio of verum (BF-200 ALA; Ameluz®) to vehicle (placebo)) clinical trial at 15 sites in the United States of America (US). Each site should randomize between 10 and 20 subjects.
Each subject will complete a clinical observation period that will last for up to 7 months (up to 4 weeks screening and pre-randomization period, and up to 6 months clinical observation period) followed by a 5-year follow-up (FU) period after the completion of the first PDT cycle.
The treatment of superficial BCC lesion(s) comprises of up to two PDT cycles each with two PDT sessions one to two weeks apart of each other. 12 weeks after the first PDT of the first cycle lesion(s) will be assessed clinically and only subjects with remaining BCC lesion(s) will be retreated in the second PDT cycle starting the same day. For clinically completely cleared subjects the clinical observation period of the study will end and these subjects will enter the FU part of the study.
For each subject a Main Target Lesion will be defined that will be excised either 12 weeks after the first PDT of the first cycle, if clinically cleared, or at the end of the clinical observation period in order to histologically confirm the clinical assessment. Additional Target Lesions will be assessed clinically, only. Randomization will be stratified by the number of lesions (1 vs ≥2 Lesion(s)).
Definitions of complete responders comprise of:
- Complete response of the Main Target Lesion which is assessed 12 weeks after the start of the last PDT cycle that included treatment of the Main Target Lesion and is defined as a Main Target Lesion that is completely clinically and histologically cleared.
- In general, clinically complete responders are categorized 12 weeks after the start of the last PDT cycle according to clinical assessment only and are defined as subjects with all lesions (Main plus Additional Target Lesions) clinically cleared.
Verum and vehicle are indistinguishable. However, treatment is accompanied with typical adverse events (AEs). In order to guarantee the blind status of the investigator assessing efficacy after each PDT cycle, a second investigator or delegated person will perform drug application and light treatment as well as all safety evaluations at visits where PDT is applied and during the phone call 1 week after each PDT cycle, respectively. Both investigators (delegated person(s)) are not entitled to exchange information about the study outcome and side effects.
- Conditions
- Superficial Basal Cell Carcinoma
- Being tested
- Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT), Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)
- Keywords
- ALA-PDT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)Combination product
Also called ALA-PDT, Ameluz®-PDT
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®.
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®.
| Study group | Role | What they receive |
|---|---|---|
| BF-200 ALA | Experimental | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
Photodynamic therapy (PDT) Receives: 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) Receives: Combination Product: Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
- Key secondary endpoint: Percentage of Main Target Lesions with complete clinical clearance (i.e. according to clinical assessment only) 12 weeks after the start of the last PDT cycle.
Measured: 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
- Key secondary endpoint: Percentage of Main Target Lesions with complete histological clearance (i.e. according to histological assessment only) 12 weeks after the start of the last PDT cycle.
Measured: 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.
- Key secondary endpoint: Percentage of subjects with complete clinical clearance of all Target Lesions (i.e. according to clinical assessment only) 12 weeks after the start of the last PDT cycle.
Measured: 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.
- Key secondary endpoint: Percentage of subjects with complete clinical and histological clearance of the Main Target Lesion and complete clinical clearance of all Additional Target Lesions 12 weeks after the start of the last PDT cycle
Measured: 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.
Further secondary endpoint: Percentage of Individual Target Lesions that are completely clinically cleared per treatment arm 12 weeks after the start of the last PDT cycle.
Measured: 12 weeks after the start of the last PDT cycle
Main Target Lesion Complete Response (Clinically and Histologically Cleared) Assessed 12 Weeks After PDT-1.
Further secondary endpoint: Percentage of Main Target Lesions that are clinically and histologically cleared 12 weeks after PDT-1.
Measured: 12 weeks after PDT-1
Main Target Lesion Clinical Response (According to Clinical Assessment Only) Assessed 12 Weeks After PDT-1.
Further secondary endpoint: Percentage of Main Target Lesions that are clinically cleared 12 weeks after PDT-1.
Measured: 12 weeks after PDT-1
Main Target Lesion Histological Response (According to Histological Assessment Only) Assessed 12 Weeks After PDT-1.
Further secondary endpoint: Percentage of Main Target Lesions that are histologically cleared 12 weeks after PDT-1.
Measured: 12 weeks after PDT-1
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 PDT-1.
Further secondary endpoint: Percentage of Individual Target Lesions that are completely clinically cleared per treatment arm 12 weeks after PDT-1
Measured: 12 weeks after PDT-1
Subject Complete Clinical Response (Complete Clearance of All Target Lesions According to Clinical Assessment Only) Assessed 12 Weeks After PDT-1.
Further secondary endpoint: Percentage of subjects with complete clinical clearance 12 weeks after PDT-1.
Measured: 12 weeks after PDT-1
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 PDT-1..
Further secondary endpoint: Percentage of subjects with complete clinical and histological clearance of the Main Target Lesion and complete clinical clearance of Additional Target Lesions 12 weeks after PDT-1.
Measured: 12 weeks after PDT-1
For All Target Lesions, Assessment of Esthetic Appearance by the Investigator 12 Weeks After the Start of the Last PDT Cycle, But Prior to Surgical Excision of the Main Target Lesion and Any Alternative Treatment of Additional Target Lesions.
Further secondary endpoint: Investigators assessment of the esthetic appearance of all Target lesions but prior to surgical excision of the Main Target Lesion or alternative Treatment of Additional Target Lesions
Measured: 12 weeks after the start of the last PDT cycle
Subjects' Satisfaction Regarding Esthetic Outcome and Treatment 12 Weeks After the Start of the Last PDT Cycle, But Prior to Surgical Excision of the Main Target Lesion or Alternative Treatment of Additional Target Lesions
Further secondary endpoint: Subject's assessment regarding the esthetic outcome and the Treatment 12 weeeks after the start of the last PDT cycle but prior to surgical excision of the Main Target Lesion or alternative Treatment of Additional Target Lesions
Measured: 12 weeks after the start of the last PDT cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start25 Sep 2018
- Primary completion19 Mar 2024
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Superficial Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biofrontera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David M. Pariser, MD, Principal investigator, Virginia Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573401
- Sponsor's protocol ID
- ALA-BCC-CT013
- Status last verified
- Dec 2025
- First submitted
- 19 Jun 2018
- Last updated
- 14 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Schlesinger T, Chapman MS, Tu JH, Cohen JL, Strasswimmer J, Zeitouni NC, Torres A, Jazayeri SS, Goldman MP, Ibrahim SF, Lain EL, Couvillion MP, Bruce S, Laquer VT, Hanke CW, Ozog DM, Schneider J, Markowitz O, Berman B, Nestor MS, Gold MH, Munavalli GS, Forsha DW, Siegel DM, Mrohs D, Schmitz B, Schaning R, Pospiech N, Lyons J, Foguet M, Lubbert M, Lubbert H, Pariser DM. Red light photodynamic therapy with 10% aminolevulinic acid gel showed efficacy for treatment of superficial basal cell carcinoma in a randomized, vehicle controlled, double-blind, multicenter phase III study. J Am Acad Dermatol. 2025 Dec;93(6):1489-1498. doi: 10.1016/j.jaad.2025.08.031. Epub 2025 Aug 20.
PubMed 40846240
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Vehicle-controlled Multicenter Phase III 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 ID
- NCT03573401
- Acronym / sponsor ID
- ALA-BCC-CT013
- Conditions
- Superficial Basal Cell Carcinoma
- Keywords
- ALA-PDT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Biofrontera Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- Feb 2029 (estimated)
- First posted
- 29 Jun 2018 (actual)
- Results
- Posted 29 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The study will be conducted as randomized, double blind and vehicle-controlled ( 4:1 ratio of verum (BF-200 ALA; Ameluz®) to vehicle (placebo)) clinical trial at 15 sites in the United States of America (US). Each site should randomize between 10 and 20 subjects.
Each subject will complete a clinical observation period that will last for up to 7 months (up to 4 weeks screening and pre-randomization period, and up to 6 months clinical observation period) followed by a 5-year follow-up (FU) period after the completion of the first PDT cycle.
The treatment of superficial BCC lesion(s) comprises of up to two PDT cycles each with two PDT sessions one to two weeks apart of each other. 12 weeks after the first PDT of the first cycle lesion(s) will be assessed clinically and only subjects with remaining BCC lesion(s) will be retreated in the second PDT cycle starting the same day. For clinically completely cleared subjects the clinical observation period of the study will end and these subjects will enter the FU part of the study.
For each subject a Main Target Lesion will be defined that will be excised either 12 weeks after the first PDT of the first cycle, if clinically cleared, or at the end of the clinical observation period in order to histologically confirm the clinical assessment. Additional Target Lesions will be assessed clinically, only. Randomization will be stratified by the number of lesions (1 vs ≥2 Lesion(s)).
Definitions of complete responders comprise of:
- Complete response of the Main Target Lesion which is assessed 12 weeks after the start of the last PDT cycle that included treatment of the Main Target Lesion and is defined as a Main Target Lesion that is completely clinically and histologically cleared.
- In general, clinically complete responders are categorized 12 weeks after the start of the last PDT cycle according to clinical assessment only and are defined as subjects with all lesions (Main plus Additional Target Lesions) clinically cleared.
Verum and vehicle are indistinguishable. However, treatment is accompanied with typical adverse events (AEs). In order to guarantee the blind status of the investigator assessing efficacy after each PDT cycle, a second investigator or delegated person will perform drug application and light treatment as well as all safety evaluations at visits where PDT is applied and during the phone call 1 week after each PDT cycle, respectively. Both investigators (delegated person(s)) are not entitled to exchange information about the study outcome and side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BF-200 ALA | Experimental | Combination Product: Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). Photodynamic therapy (PDT) |
| Vehicle | Placebo comparator | Combination Product: Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)Topical application of vehicle to BF-200 ALA containing no active ingredient. Photodynamic therapy (PDT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (33 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)Also: ALA-PDT, Ameluz®-PDTThe 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®. | Combination product | BF-200 ALA |
| Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)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®. | Combination product | Vehicle |
Primary outcome
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.
Time frame: 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).
13 secondary outcomes
Main Target Lesion Clinical Response Rate (According to Clinical Assessment Only) Assessed 12 Weeks After the Start of the Last PDT Cycle
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks after the start of the last PDT cycle
Main Target Lesion Complete Response (Clinically and Histologically Cleared) Assessed 12 Weeks After PDT-1.
Time frame: 12 weeks after PDT-1
Main Target Lesion Clinical Response (According to Clinical Assessment Only) Assessed 12 Weeks After PDT-1.
Time frame: 12 weeks after PDT-1
Main Target Lesion Histological Response (According to Histological Assessment Only) Assessed 12 Weeks After PDT-1.
Time frame: 12 weeks after PDT-1
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 PDT-1.
Time frame: 12 weeks after PDT-1
Subject Complete Clinical Response (Complete Clearance of All Target Lesions According to Clinical Assessment Only) Assessed 12 Weeks After PDT-1.
Time frame: 12 weeks after PDT-1
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 PDT-1..
Time frame: 12 weeks after PDT-1
For All Target Lesions, Assessment of Esthetic Appearance by the Investigator 12 Weeks After the Start of the Last PDT Cycle, But Prior to Surgical Excision of the Main Target Lesion and Any Alternative Treatment of Additional Target Lesions.
Time frame: 12 weeks after the start of the last PDT cycle
Subjects' Satisfaction Regarding Esthetic Outcome and Treatment 12 Weeks After the Start of the Last PDT Cycle, But Prior to Surgical Excision of the Main Target Lesion or Alternative Treatment of Additional Target Lesions
Time frame: 12 weeks after the start of the last PDT cycle
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40846240Schlesinger T, Chapman MS, Tu JH, Cohen JL, Strasswimmer J, Zeitouni NC, Torres A, Jazayeri SS, Goldman MP, Ibrahim SF, Lain EL, Couvillion MP, Bruce S, Laquer VT, Hanke CW, Ozog DM, Schneider J, Markowitz O, Berman B, Nestor MS, Gold MH, Munavalli GS, Forsha DW, Siegel DM, Mrohs D, Schmitz B, Schaning R, Pospiech N, Lyons J, Foguet M, Lubbert M, Lubbert H, Pariser DM. Red light photodynamic therapy with 10% aminolevulinic acid gel showed efficacy for treatment of superficial basal cell carcinoma in a randomized, vehicle controlled, double-blind, multicenter phase III study. J Am Acad Dermatol. 2025 Dec;93(6):1489-1498. doi: 10.1016/j.jaad.2025.08.031. Epub 2025 Aug 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M. Pariser, MD principal investigator
Virginia Clinical Research, Inc.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) in people with Superficial Basal Cell Carcinoma, run by Biofrontera Inc. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 weeks after the start of the last PDT cycle that included treatment of the Main Target Lesion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03573401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.