Study to Evaluate Safety and Tolerability of BF-200 ALA (Ameluz®) for Photodynamic Therapy in the Treatment of the Expanded Field of Actinic Keratosis on Face and Scalp

NCT05060237 | Completed Phase 1 Results FDA Drug FDA Device

• 1 other identifier: ALA-AK-CT018
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 9

Brief Summary

The aim of the study is to evaluate the safety and tolerability of PDT for treatment of mild to severe actinic keratosis on the face and scalp in the expanded treatment field using 3 tubes of BF-200 ALA 10% gel (Ameluz®) in conjunction with the BF-RhodoLED® XL PDT lamp.

Conditions

Actinic Keratosis; Keratosis, Actinic; Keratosis

Keywords

Actinic keratosis; Photodynamic therapy; 5-aminolevulinic acid; Photosensitizing Agents; Dermatologic Agents; Precancerous condition; Skin Disease

Outcome Measures

Primary Outcomes (16)

• Frequency and Severity of Adverse Events (AEs), Serious AEs (SAEs), and Treatment Emergent Adverse Events (TEAEs).

  TEAEs are defined as all AEs with onset or worsening after treatment with IMP up to Visit 5 (Final Visit). TEAEs are considered being related to IMP or medical device, if causal relationship between IMP or medical device and the TEAE is at least possible or relationship assessment is missing. If an AE occurs in different treatment areas (face, scalp, face and scalp), it is reported separately for each treatment area. Thus, some AEs are counted more than once.

  Through study completion, on average 6 weeks

• Duration of TEAEs Including the Breakdown of Severity Category (Mild, Moderate, Severe).

  The duration of TEAEs related to IMP and/or medical device which occurred in at least two subjects and with complete start and stop dates was analyzed. In addition, the proportion of the duration by severity was analyzed. Duration of severity per subject and preferred term is calculated in days counting all days and all episodes of one severity category together. Calculation is done referring to all subjects with occurrence of respective preferred term. If a severity category of a preferred term does not occur in a subject, the duration of this category is set to 0. If an AE occurs in different treatment areas, it is reported separately for each treatment area (face, scalp, face and scalp). Thus, some AEs are counted more than once for the analysis.

  From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment)

• Assessment of New Lesions (AK, NMSC Such as BCC, SCC or Bowens Disease, and Melanoma) if They Occur Inside the Treatment Field

  Assessed were newly occuring lesions of actinic keratosis (AK), non-melanoma skin cancer (NMSC) such as basal cell carcinoma (BCC), squamous cell carcinoma (SCC) or Bowens disease, and melanoma inside the treatment field. Cumulative number of lesions is reported.

  From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment)

• Assessment of New Lesions (AK, NMSC, and Melanoma) if They Occur Around the Treatment Field at a Distance of <10 cm

  Assessed were newly occuring lesions of actinic keratosis (AK), non-melanoma skin cancer (NMSC) such as basal cell carcinoma (BCC), squamous cell carcinoma (SCC) or Bowens disease, and melanoma inside the treatment field. Cumulative number of lesions is reported.

  From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment)

• Application Site Skin Reactions During and Post PDT, Assessed by the Investigator

  Application site skin reaction categories: discharge, erosion, erythema, exfoliation, fissure, induration, oedema, scabbing, skin flaking, ulceration, vesicles, other; severity of AE: mild, moderate or severe

  From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment)

• Application Site Discomfort During and Post PDT, Reported by the Subjects

  Application site discomfort categories: burning, hyperaesthesia, pain, paraesthesia, pruritus, stinging, warmth, other; severity of AE: mild, moderate or severe

  From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment)

• Application Site Pain During Illumination

  Assessed by the subjects using an 11-point numeric rating scale (NRS), where a score of 0 means "no pain" and a score of 10 means "worst imaginable pain".

  At treatment day (day 1, Visit 2) after end of illumination

• Changes in Blood Pressure (Systolic and Diastolic)

  Change from baseline is presented. The first measurement at Visit 2 (arrival at site) was considered as baseline value for all following measurements. Blood pressure was measured in mmHg. At Visit 2, photodynamic therapy was performed.

  All visits through study completion after Visit 1: Visit 2, baseline, treatment day; Visit 3, approx. 7 days post treatment; Visit 4, approx.14 days post treatment; Visit 5, approx. 28 days post treatment

• Changes in Pulse Rate

  Change from baseline is presented. The first measurement at Visit 2 (arrival at the site) was considered as baseline value for all following measurements. Pulse rate was measures in beats/min. At Visit 2, photodynamic therapy was performed.

  All visits through study completion after Visit 1: Visit 2, baseline, treatment day; Visit 3, approx. 7 days post treatment; Visit 4, approx.14 days post treatment; Visit 5, approx. 28 days post treatment

• Changes in Body Temperature

  Change from baseline is presented. The first measurement at Visit 2 (arrival at site) was considered as baseline value for all following measurements. Body temperature was measured in °F and was converted to °C in the electronic Case Report Form. At Visit 2, photodynamic therapy was performed.

  All visits through study completion after Visit 1: Visit 2, baseline, treatment day; Visit 3, approx. 7 days post treatment; Visit 4, approx.14 days post treatment; Visit 5, approx. 28 days post treatment

• Investigation of Clinical Chemistry Parameters

  Findings which differ from reference range and are considered to be clinically significant are to be reported. Clinical chemistry parameters include glucose, creatinine, total bilirubin, aspartate aminotransferase (AST), alanineaminotransferase (ALT), lactate dehydrogenase (LDH), alkalinephosphatase (AP),gamma glutamyl transferase (GGT), potassium, sodium, calcium, total protein, albumin.

  At screening (Visit 1, up to 14 days before treatment) and at Visit 5 (approx. 28 days post treatment)

• Investigation of Hematology Parameters

  Findings which differ from reference range and are considered to be clinically significant are to be reported. Hematology parameters include hemoglobin, hematocrit, red blood cell count, leukocyte count (white blood cells(WBC)) with differential count (neutrophils, lymphocytes, monocytes, eosinophils, basophils), and platelet count.

  At screening (Visit 1, up to 14 days before treatment) and at Visit 5 (approx. 28 days post treatment)

• Investigation of Urinalysis Parameters

  Findings which differ from reference range and are considered to be clinically significant (CS) are to be reported

  At screening (Visit 1, up to 14 days before treatment) and at Visit 5 (approx. 28 days post treatment)

• Physical Examination of Head, Neck, Skin, Lymph Nodes, Thorax Including Heart and Lungs, Abdomen, and Musculoskeletal, Peripheral Vascular and Nervous System Status

  Abnormal findings, considered to be clinically significant (CS), are to be reported

  At screening (Visit 1, up to 14 days before treatment) and at Visit 5 (approx. 28 days post treatment)

• Memory Tests

  Including picture- and question-based memory tasks; abnormal findings that are considered clinically significant will be documented

  At screening (Visit 1, up to 14 days before treatment) and at Visit 2 (treatment day 1)

• Neurological Investigations

  Including investigation of pupils (equality), coordination (finger-nose test), gait (balance), and sensitivity (cheeks, arms, legs); abnormal findings that are considered clinically significant (CS) will be documented

  At screening (Visit 1, up to 14 days before treatment) and at Visit 2 (treatment day 1)

Study Arms (1)

BF-200 ALA

EXPERIMENTAL

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

Combination Product: BF-200 ALA and red light LED lamp

Interventions

BF-200 ALA and red light LED lamp COMBINATION_PRODUCT

Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT): Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²), followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing.

BF-200 ALA

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.
• Subjects with mild to severe clinically confirmed AK lesions (according to Olsen) on the face and/or scalp. In case of severe AK lesions, a biopsy must be taken for confirmation of diagnosis. At least 8 mild to moderate AK lesions with a diameter of ≥4 mm must be present in the treatment field. The treatment field (continuous or in several patches) totaling about 60 cm2 must be located within one effective illumination area. The AK lesions should be clearly distinguishable, without restrictions on the distance between lesions. Lesions should have a minimal distance of 1 cm between the lesion margin and the border of the treatment field.
• All sexes, ≥18 years of age.
• Willingness and ability to comply with study procedures, particularly willingness to receive a PDT session and to undergo 2 mm punch biopsy/biopsies in case of severe AK lesion(s) at the screening visit.
• 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 visits.
• Acceptance to abstain from extensive sunbathing and the use of a solarium or tanning beds during the study.
• For female subjects with reproductive potential: Negative serum pregnancy test.
• For female subjects with reproductive potential: Effective contraception at screening visit and throughout the study.

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.
• Subjects with sunburn or other possible confounding skin conditions (e.g. wounds, irritations, bleeding or skin infections) inside or in close proximity (\<10 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, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, other malignant or benign tumors inside or in close proximity (\<10 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 Bioscience GmbH: lead

Study Sites (9)

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

Laser and Skin Surgery Center of Indiana

Indianapolis, Indiana, 46260, 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

Houston, Texas, 77056, United States

Location

Austin Institute for Clinical Research Inc.

Pflugerville, Texas, 78660, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic; Keratosis; Precancerous Conditions; Skin Diseases

Interventions

BF-200 ALA

Condition Hierarchy (Ancestors)

Neoplasms; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Trial Department
• Organization: Biofrontera Bioscience GmbH

ameluz@biofrontera.com

+49 214 876 32

Study Officials

• Todd Schlesinger, MD

  Clinical Research Center of the Carolinas, 1364 Ashley River Road, Charleston, SC 29407, USA

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 29, 2021
• Study Start: December 1, 2021
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)