Actinic keratosis MedDRA version: 18.1 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Ameluz®
Product Name: Ameluz®
Product Code: BF-200 ALA
Pharmaceutical Form: Gel
INN or Proposed INN: 5-aminolaevulinic acid
CAS Number: 5451-09-2
Other descriptive name: AMINOLEVULINIC ACI
Sponsors
Biofrontera Bioscience GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Males or females between 18 and 85 years of age (inclusive) • Willing and able to sign the informed consent form. A study-specific informed consent must be obtained in writing for all patients before starting any study procedures. • Presence of 3 to 9 clinically confirmed AK target lesions of mild to moderate intensity, i.e. AK grade 1 or 2 according to Olsen et al 1991(Olsen et al., 1991), within each of 2 comparable treatment areas located either on opposite sides of the face (excluding eyes, nostrils, ears, and mouth) and/or the scalp. The number of lesions should not vary by more than 50% between the two sides for each patient. • AK lesions must be discrete and measurable; the diameter of each AK lesion should be between 0.5 cm and 1.5 cm. • Willingness to undergo a biopsy at each patient’s side at the end-of-clinical observation period visit 12 weeks after the last PDT • Free of significant physical abnormalities (e.g. tattoos, dermatoses) in the potential treatment areas that may complicate examinations or final evaluations • Willingness to stop the use of moisturizers and any other topical treatments within the treatment area(s) 24 h before and 48 h after PDT and within approximately 24 h before a clinical visit that involves lesion counts. • Accept to abstain from extensive sunbathing and the use of a solarium during the period of the clinical visits except period of daylight PDT. Patients experiencing sunburn within the treatment areas cannot be included until they have fully recovered. • Good general health and/or stable health condition, as confirmed by a physical examination and medical history • Healthy patients and patients with clinically stable medical conditions including, but not limited to, the following diseases: controlled hypertension, diabetes mellitus type II, hypercholesterolemia, and osteoarthritis will be permitted to be included into the study if the medication taken for the treatment of the disease does not match an exclusion criterion or is specified as prohibited concomitant medication. • Negative pregnancy test at screening, if appropriate • Effective contraception in women of childbearing potential Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38
Exclusion criteria
Exclusion criteria: • History of hypersensitivity to 5-ALA, MAL or any ingredient of Ameluz® or Metvix® • Current treatment with immunosuppressive therapy • Presence of porphyria • Hypersensitivity to porphyrins • Presence of photodermatoses • Presence of other malignant or benign tumors of the skin within the treatment areas (e.g. malignant melanoma, basal cell carcinoma [BCC] or squamous cell carcinoma [SCC]) within the last 4 weeks prior to PDT (V2)). • Presence of an inherited or acquired coagulation defect • Known confirmed diagnosis of human immunodeficiency virus (HIV) based on clinical history • Start of treatment with phototoxic or photoallergic drugs within 8 weeks prior to screening • Clinically significant (CS) medical conditions (tumor disease etc.) making implementation of the protocol or interpretation of the study results difficult • Evidence of CS, unstable medical conditions such as: - Metastatic tumor or tumor with high probability of metastasis - Cardiovascular disease (New York Heart Association [NYHA] class III, IV) - Immunosuppressive condition -Hematologic, hepatic, renal, neurologic, or endocrine condition - Collagen-vascular condition - Gastrointestinal condition • Use of any medicinal topical treatment in the treatment areas within 12 weeks before PDT • Any physical treatments for melanoma, AK and NMSC within the treatment areas in the last 4 weeks before PDT • Topical treatment with immunomodulatory or cell toxic agents (e.g. imiquimod, ingenol mebutate, 5-FU) or ALA or MAL within 12 weeks prior to the PDT session and during the clinical observation period (except the study specific treatment with Ameluz® and Metvix®) • Any of the specified systemic treatments within the designated period before PDT and during the clinical observation period • Presence of tattoos, skin inflammation, wounds etc. in close proximity to the treatment area
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to compare the efficacy and safety of Ameluz® treatment of mild to moderate AK with Metvix® when using daylight PDT. ;Secondary Objective: The secondary objectives of the study are to evaluate the safety and secondary efficacy parameters related to Ameluz® or Metvix® for the treatment of AK PDT when using daylight PDT.;Primary end point(s): The primary efficacy variable is the total lesion clearance rate in percent per patient’s side, defined as the percentage of individual lesions with complete remission on the respective side of the patient assessed 12 weeks after PDT.;Timepoint(s) of evaluation of this end point: see definition in sec. E.5.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Total lesion clearance, defined as the number of completely cleared individual lesions 12 weeks after PDT per patient’s side • Total lesion clearance, defined as the number of completely cleared individual lesions of mild or moderate severity (according to Olsen criteria 1 or 2 ) at baseline 12 weeks after PDT per patient’s side • Total lesion clearance, defined as the number of completely cleared individual lesions, separately by face and scalp 12 weeks after PDT per patient’s side • Patient complete clearance per patient’s side, i.e. all lesions cleared at the respective patient’s side • Patient histologically confirmed response rate (HCR) per patient’s side • p53 expression per patient’s side in one biopsy on each side taken at the end-of-observer-blind period • Reduction of total lesion area (the size of all treated lesions added up) per patient 12 weeks after PDT per patient’s side • The change in skin quality assessments compared to baseline assessed 12 weeks after PDT per patient’s side • The overall cosmetic outcome 12 weeks after PDT per patient’s side • Patient’s satisfaction on cosmetic outcome (per patient side) and therapy (per patient’s side and global);Timepoint(s) of evaluation of this end point: see definition ind sec. E.5.2 | — |
Countries
Germany, Spain
Contacts
Public ContactClinical Trial Department
Biofrontera Bioscience GmbH
Outcome results
None listed