Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Dermatitis, Phototoxic

Skin Diseases

Precancerous Conditions

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

Photosensitizing Agents

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

Red light photodynamic therapy (PDT)

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

Up to two PDTs using a RhodoLED lamp (RhodoLED® XL or BF-RhodoLED®) (ALA-PDT, Ameluz®-PDT):

Topical application of up to 3 tubes BF-200 ALA on the expanded treatment field (up to 240 cm²), followed by red light illumination with a RhodoLED lamp after 3 h incubation of study medication under occlusive dressing.

PDT-1 will be performed at Visit 2. Clinical clearance will be assessed 12 weeks after PDT-1 (Visit 4). In case of remaining lesions at Visit 4, PDT-2 will be performed at the same visit.

BF-200 ALA and red light LED lamp

Up to two PDTs using a RhodoLED lamp (RhodoLED® XL or BF-RhodoLED®) (Vehicle-PDT):

Topical application of up to 3 tubes vehicle on the expanded treatment field (up to 240 cm²), followed by red light illumination with a RhodoLED lamp after 3 h incubation of study medication under occlusive dressing.

PDT-1 will be performed at Visit 2. Clinical clearance will be assessed 12 weeks after PDT-1 (Visit 4). In case of remaining lesions at Visit 4, PDT-2 will be performed at the same visit.

Vehicle and red light LED lamp

Beate Schmitz, PhD

Corinna Zogel, PhD

Nathalie Zeitouni, MD

Sasha Jazayeri, MD

Joel Cohen, MD

John Strasswimmer, MD

Jonathan S. Weiss, MD

C. William Hanke, MD

John H. Tu, MD

Sherrif F. Ibrahim, MD

Todd Schlesinger, MD

Megan Poynot Couvillion, MD

Edward L. Lain, MD

The aim of this study is to test the safety. tolerability and efficacy of field-directed photodynamic therapy (PDT) with 10% aminolevulinic acid gel (Ameluz®, BF-200 ALA) in combination with one of the narrow spectrum red light RhodoLED lamps in comparison to vehicle treatment for actinic keratosis (AK) on the extremities and neck/trunk.

Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp

A Randomized, Double-blind, Vehicle-controlled, Multicenter Phase III Study to Evaluate the Safety, Tolerability, and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using the BF-RhodoLED® XL or BF-RhodoLED® Lamp

The percentage of subjects with all AK target lesions clinically cleared 12 weeks after the last PDT presenting with at least one recurrent lesion during follow-up, stratified by demographics, study sites, AK baseline parameters

The percentage of AK target lesions showing recurrence in follow-up in relation to total number of clinically cleared AK target lesions 12 weeks after last PDT; overall and stratified by treatment area and AK severity at baseline (according to Olsen \[mild, moderate, severe\])

The percentage of severe AK lesions (according to Olsen \[mild, moderate, severe\]) showing recurrence in follow-up in relation to total number of clinically cleared severe AK lesions 12 weeks after last PDT; overall and stratified by treatment area

The esthetic outcome at follow-up visits as assessed by the subject according to a 4-point scale ranging from 0 (=very good) to 3 (=unsatisfactory); overall and stratified by treatment area

Satisfaction with PDT treatment after the last PDT as assessed by the subject via questionnaire, 1. if they would chose PDT treatment in the future in case of recurrence or similar disease (yes/no) and 2. how they would rate the PDT treatment in comparison to other treatment modalities, if applicable (better than/ similar/ worse). The treatment modalities should be documented, if applicable); overall and stratified by treatment area

Relevant AEs include AEs or conditions affecting skin health in the treatment field which may impair proper assessment of the recurrence rate of the treated AK lesions, or other clinically relevant events at the investigator's discretion as well as any SAE that has occurred since the final visit of the treatment phase (Visit 4 or Visit 6); overall and stratified by demographics and treatment area

New lesions: AK, non-melanoma skin cancer \[NMSC, including BCC, SCC or BD\] or melanoma

Percentage of subjects with all AK target lesions clinically cleared after last PDT

Percentage of subjects with all AK target lesions on extremities clinically cleared after last PDT

Percentage of subjects with all AK target lesions on neck/trunk clinically cleared after last PDT

Percentage of clinically cleared individual AK target lesions in relation to total number of AK target lesions at baseline (Visit 2) after the last PDT, overall and stratified by treatment area and AK severity at baseline (according to Olsen)

Percentage of clinically cleared individual severe AK lesions in relation to total number of severe AK lesions at baseline (according to Olsen; Visit 2) after the last PDT, overall and stratified by treatment area

Percentage of subjects with all AK target lesions clinically cleared after PDT-1, overall and stratified by AK baseline parameters

Percentage of clinically cleared individual AK target lesions in relation to total number of AK target lesions at baseline (Visit 2) after PDT-1, overall and stratified by treatment area and AK severity at baseline (according to Olsen \[mild, moderate, severe\])

Percentage of clinically cleared individual severe AK lesions in relation to total number of severe AK lesions at baseline (according to Olsen \[mild, moderate, severe\]; Visit 2) after PDT-1, overall and stratified by treatment area

The esthetic appearance after the last PDT as assessed by the investigator as assessed by the subject according to a 4-point scale ranging from 0 (=very good) to 3 (=unsatisfactory); overall and stratified by treatment area

The esthetic outcome after the last PDT as assessed by the subject according to a 4-point scale ranging from 0 (=very good) to 3 (=unsatisfactory); overall and stratified by treatment area

Frequency and extent of AEs, AESIs, SAEs, and TEAEs, overall and stratified by demographics, skin type class (I-III and IV-VI), size of the treatment field, and treatment area.

TEAEs (including application site skin reactions and discomfort) are defined as all AEs with onset or worsening after treatment with IMP.

New lesions: AK, non-melanoma skin cancer \[NMSC, including Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC) or Bowen's Disease (BD)\] or melanoma

Application site reactions (bleeding, burning, discharge, edema, erosion, erythema, exfoliation, hyperalgesia, induration, irritation, paraesthesia, pruritus, pustules, scabbing, or vesicles) will be assessed on a 4-point scale: grade 0 = none, grade 1 = mild, grade 2 = moderate, grade 3 = severe.

Reported by the subjects assessed on an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain); overall and stratified by size of the treatment field and treatment area

Number of patients with changes in blood pressure (systolic and diastolic) \[mmHg\] and changes in pulse rate \[beats/min\]. Findings which differ from reference range and are considered to be clinically significant are to be reported.

Changes in clinical chemistry, in hematology and urinalysis parameters as defined in the protocol. Findings which differ from reference range and are considered to be clinically significant are to be reported.

Physical examination of head, neck, skin, lymph nodes, thorax including heart and lungs, abdomen, and musculoskeletal, peripheral vascular and nervous system status will be performed. Abnormal findings, considered to be clinically significant, are to be reported.

Biofrontera Bioscience GmbH

Carcinoma

Carcinoma, Basal Cell

Neoplasms, Basal Cell

Dermatitis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Dermatitis, Irritant

Dermatitis, Contact

Photosensitivity Disorders

Skin Diseases, Eczematous

Methyl 5-aminolevulinate

Fluoxymesterone

2% Hexylaminolevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream

78 mg/g Aminolevulinic Acid Nano Emulsion

The cream is mixed up by the Pharmacy Yliopiston Apteekki for the study and every set is analysed by mass spectrometry.

Hexylaminolevulinate cream

Aminolevulinic Acid Nano Emulsion

Methylaminolevulinate cream

Mari Grönroos, MD, PhD

Mari K Salmivuori, MD

This pilot study compares three photosensitisers, hexylaminolevulinate (HAL) and aminolevulinic acid nano emulsion (BF-200 ALA) to methylaminolevulinate (MAL) in photodynamic therapy of superficially growing basal cell carcinomas. Study is conducted using randomised prospective double blinded comparing design. Fluorescence is measured in A.U. (Arbitrary Unit) with standardised set-up before and after the exposure. Efficacy is assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5 years.

Study recruits volunteering patients, who are referred to the department of dermatology and allergology, Päijät-Häme Central Hospital, Lahti, with 99 clinically assessed superficial basal cell carcinoma on the body area, not face and scalp. Diagnoses is confirmed histologically by punch biopsies and hyperspectral images are taken before the biopsies. The lesions are randomised in three groups: interventions HAL and BF-200 ALA and comparator MAL. Photodynamic therapy is given by the standard procedure. Fluorescence is measured in A.U. (Arbitrary Unit) with standardised set-up, with Wood's light, digital camera and a yellow lens, before and after the exposure. Pain is measured in VAS-scale before, during and after the exposure. Efficacy is assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5 years.

Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: HAL and BF-200 ALA Versus MAL

Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: Hexylaminolevulinate and Aminolevulinic Acid Nano Emulsion Versus Methylaminolevulinate

Tampere University

University of Jyvaskyla

Joint Authority for Päijät-Häme Social and Health Care

Nervous System Diseases

Symptoms and General Pathology

Rare Diseases

Glioma

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasm, Residual

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Brain Diseases

Central Nervous System Diseases

Neoplastic Processes

Neuroepithelioma

Central Nervous System Depressants

Pharmaceutical Solutions

Anesthetics

Patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy

Gliolan® is presented as a powder for oral solution in 60 ml colorless glass vials and is administered orally three hours (range 2-4 hours) before anaesthesia. One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl). The recommended dose is 20 mg 5-ALA HCl per kilogram body weight. One ml of reconstituted solution contains 23.4 mg of 5-ALA, corresponding to 30 mg 5-ALA HCl.

5-Aminolevulinic Acid (5-ALA) Gliolan®

During the surgical exploration of the glioma, the neurosurgeon will attempt to identify the mass. The location of the tumor will be assessed using the blue-light filtered microscope. A biopsy of the fluorescent region will be taken to confirm the glioma subtype. The tumor will then be maximally resected.

Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)

Alberto Valarezo Chuchuca, MD

The goal of this observational study is to evaluate disease-free survival (DFS) in patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy

The investigators are proposing a study that provides descriptive understanding of patients with High-Grade Gliomas in Ecuador. The primary objective of this pilot study is to lay the foundations for the development of a multicenter registry patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy, which will provide high-quality real data and serve as a basis for the application to future projects and elaboration of public policies in the medium and long term.

5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas

Disease-Free-Survival calculates the time from treatment until the recurrence of disease or death after undergoing Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)

Overall survival is defined as time from initiation to death of any cause

The questionnaire provides an additional set of disease-specific questions pertaining to brain neoplasms. It consists of 46 items that refer to general issues of quality of life and specific to tumor location. Possible scores range from 0 to 108, with higher scores indicating better quality of life.

The average length of stay in hospitals is often used as an indicator of efficiency. The ALOS refers to the average number of days that patients spend in hospital after surgery. It is calculated by dividing the number of bed-days by the number of discharges after procedure. Average length of stay range from 1 day to 4.5 days. Longer than average stays are usually a symptom of poor communication, quality of care, and effectiveness of treatment.

Sociedad de Lucha Contra el Cáncer del Ecuador

Facies

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

One single photodynamic therapy (PDT).

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.

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.

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

A Non-randomized, Open-label, Multicenter Study to Evaluate the Safety and Tolerability of BF-200 ALA (Ameluz®) in the Expanded Field-directed Treatment of Actinic Keratosis on the Face and Scalp With Photodynamic Therapy (PDT)

TEAEs are defined as all AEs with onset or worsening after treatment with IMP up to Visit 5 (approx. 28 days post treatment)

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

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

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

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

Abnormal findings, considered to be clinically significant, are to be reported

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp	NCT05662202	Actinic Keratos...	BF-200 ALA and ... Vehicle and red...	18 Years -	Biofrontera Bioscience GmbH
Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: HAL and BF-200 ALA Versus MAL	NCT02367547	Neoplasms, Basa... Carcinoma, Basa... Photochemothera... Photosensitizin...	Hexylaminolevul... Aminolevulinic ... Methylaminolevu...	18 Years -	Joint Authority for Päijät-Häme Social and Health Care
5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas	NCT05850377	High Grade Glio... Glioma Glioma, Maligna... Neoplasms, Neur... Neuroectodermal... Photosensitizin... Neoplasm Malign... Brain Neoplasms... Central Nervous... Brain Tumor Tumour, Residua...	5-Aminolevulini... Fluorescence-Gu...	18 Years - 75 Years	Sociedad de Lucha Contra el Cáncer del Ecuador
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	Actinic Keratos... Keratosis, Acti... Keratosis	BF-200 ALA and ...	18 Years -	Biofrontera Bioscience GmbH
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	Actinic Keratos... Keratosis, Acti... Keratosis	BF-200 ALA and ...	18 Years -	Biofrontera Bioscience GmbH

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