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.

Spots Global Cancer Trial Database for vehicle and red light led lamp