Study to Evaluate the Safety of BF-200 ALA (Ameluz®) for Photodynamic Therapy (PDT) in the Treatment of Expanded Fields of Actinic Keratosis (AK)

NCT04319159 | Completed Phase 1 Results FDA Drug FDA Device

• 1 other identifier: ALA-AK-CT015
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the pharmacokinetics (PK) of the parent drug 5-aminolevulinic acid (ALA) and its active metabolite protoporphyrin IX (PpIX) during photodynamic therapy with 3 tubes of BF-200 ALA 10% gel (Ameluz®) in combination with the BF-RhodoLED® lamp in the systemic circulation of diseased individuals presenting with actinic keratosis (AK) on the face/scalp or in the periphery (neck/trunk/extremities) along with subjects' safety/tolerability during and after treatment.

Conditions

Actinic Keratoses

Keywords

Actinic keratosis; Photodynamic therapy; 5-aminolevulinic acid; Protoporphyrin IX; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Assessment of Baseline-adjusted Plasma Concentration-time Curves for ALA After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.

  Blood samples for ALA analysis for each subject were collected, starting at Visit 1 and then 0.5h prior to BF-200 ALA application for up to 10h afterwards. The concentrations of ALA in plasma were measured by an analytical laboratory using validated, internally standardized liquid chromatography-tandem mass spectrometry methods.

  On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

• Assessment of Baseline-adjusted Plasma Concentration-time Curves for PpIX After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.

  Blood samples for PpIX analysis for each subject were collected, starting at Visit 1 and then 0.5h prior to BF-200 ALA application for up to 10h afterwards. The concentrations of PpIX in plasma were measured by an analytical laboratory using validated, internally standardized liquid chromatography-tandem mass spectrometry methods.

  On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

Secondary Outcomes (18)

• Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.

  On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

• Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.

  On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

• Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.

  On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

• Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.

  On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

• Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.

  On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

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

Combination Product: Photodynamic therapy (PDT) using BF-RhodoLED® (ALA-PDT, Ameluz®-PDT).

BF-200 ALA

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with at least 12 distinctive and clinically confirmed mild to severe AK lesions (according to Olsen et al. 1991 (37)) with a diameter of ≥ 4 mm each, on either the face/scalp (including forehead, excluding eyes, nostrils, ears, and mouth) or the neck/trunk/extremities, within treatment field(s) of about 60 cm² in total. Treatment field(s) may be discontinuous but must be within 2 illumination areas of the BF-RhodoLED® lamp (6 cm x 16 cm each).
• All genders 18-85 years of age (inclusive).
• Willingness and ability of the subject to provide informed consent and to sign the Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent form and HIPAA form must be obtained in writing for all subjects prior to starting any study procedures.
• Willingness and ability to comply with study procedures, particularly willingness to receive one PDT with up to two illumination devices simultaneously.
• Subjects with good general health and subjects with clinically stable medical conditions will be permitted to be included in the study.
• Subjects receiving any drugs affecting coagulation (e.g. anticoagulants, anti-platelet drugs) should be on a stable dose.
• Acceptance to abstain from extensive sunbathing and the use of solarium during the clinical study.
• Women of child-bearing potential must have a negative serum pregnancy test and must use an adequate and highly effective or two effective methods of contraception 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 within illumination areas (reassessment of subjects is allowed once if the sunburn is expected to resolve within the screening period. Reassessment can be done on the day of the actual treatment.).
• Clinically significant medical conditions making implementation of the protocol or interpretation of the study results difficult or impairing subjects' safety such as:
• Presence of porphyria or known photodermatoses
• Known diagnosis of human immunodeficiency virus (HIV) based on clinical history
• Metastatic tumor or tumor with high probability of metastasis
• Infiltrating skin neoplasia (suspected or known)
• Unstable cardiovascular disease (New York Heart Association \[NYHA\] 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, BCC, eczema, psoriasis, rosacea, SCC, other malignant or benign tumors in the treatment field(s), or other possible confounding skin conditions (e.g. wounds, irritations, bleeding or skin infections) within or in close proximity (\< 5 cm distance) to treatment field(s). (Reassessment of subjects is allowed once if wounds, irritations, bleeding or skin infections are expected to resolve within the screening period. Reassessment can be done on the day of the actual treatment.)

Sponsors & Collaborators

• Biofrontera Bioscience GmbH: lead

Study Sites (1)

DermResearch Inc.

Austin, Texas, 78759, United States

Location

Related Publications (1)

• Novak B, DuBois J, Chahrour O, Papusha T, Hirt S, Philippi T, Zogel C, Osenberg K, Schmitz B, Lubbert H. Clinical Pharmacokinetics and Safety of a 10% Aminolevulinic Acid Hydrochloride Nanoemulsion Gel (BF-200 ALA) in Photodynamic Therapy of Patients Extensively Affected With Actinic Keratosis: Results of 2 Maximal Usage Pharmacokinetic Trials. Clin Pharmacol Drug Dev. 2022 Apr;11(4):535-550. doi: 10.1002/cpdd.1023. Epub 2021 Oct 11.

  PMID: 34633154 DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

BF-200 ALA

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

ameluz@biofrontera.com

+49 214 876 32

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: March 10, 2020
• First Posted: March 24, 2020
• Study Start: March 5, 2020
• Primary Completion: September 9, 2020
• Study Completion: October 7, 2020
• Last Updated: November 11, 2021
• Results First Posted: November 11, 2021

Record last verified: 2021-10

Locations

US (1)