Neoplasms

All Conditions

Carcinoma

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

Methyl 5-aminolevulinate

Photosensitizing Agents

Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and 0.5 to 1 cm of surrounding margin.

Topical application of Metvix creme containing 160 mg/g methyl-aminolevulinate. Application of a 1 mm thick layer covering each lesion and 0.5 to 1 cm of surrounding margin.

Topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation)

BF-200 ALA

methyl-aminolevulinate

Rolf M. Szeimies, Prof. Dr.

Colin Morton, Dr.

The aim of this study is to test the effectiveness and safety of the medicine Ameluz® (5-aminolevulinic acid) in comparison to methyl-aminolevulinate (MAL), used with photodynamic therapy (PDT), to treat thin, non-aggressive BCC (basal cell carcinoma).

The treatment comprises of up to 2 PDT cycles, each with two PDT sessions one week apart.

If 12 weeks after the the second PDT all lesions are completely cleared the patient will enter the follow-up phase. In case of remaining lesions the patient will receive a second PDT cycle starting on the same day.

Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy

A Randomized, Observer Blind, Multinational Phase III Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) in Comparison to Metvix® in the Treatment of Non-aggressive Basal Cell Carcinoma (BCC) With Photodynamic Therapy (PDT)

Patient recurrence rate defined as the number of patients with at least one recurrent lesion during FU after complete clearance 12 weeks after the last PDT

Lesion recurrence rate defined as the number of completely cleared lesions 12 weeks after the last PDT showing recurrence during FU. Overall and subgroup analysis (nodular basal cell carcinoma (nBCC) and superficial basal cell carcinoma (sBCC)).

Overall patient complete response rate assessed 12 weeks after the last PDT. The indicated values give the percentage of overall complete responders. An overall complete responder is defined as a patient in whom all treated lesions were cleared. The PP set is the primary analysis set for the analyses of the primary endpoint.

Lesion complete response (completely cleared individual lesions) assessed 12 weeks after the last PDT. The indicated values give percentage of overall completely cleared individual lesions. The PP set is the primary analysis set for the analysis of the secondary endpoint.

Reduction of total lesion area (summation of sizes of all treated lesions) per patient, assessed 12 weeks after the last PDT. The PP set is the primary analysis set for the analysis of the secondary endpoint.

Please note that the high SD for BF-200 ALA is due to a patient who had increased lesion area fom 63 mm² at baseline to 225 mm² 12 weeks after PDT. This lesion area included a lesion that was later confirmed to be benign skin condition (lentigo solaris).

Patient complete response (complete clearance of all treated lesions) assessed 12 weeks after PDT-2 (first PDT cycle). The PP set is the primary analysis set for the analysis of the secondary endpoint.

Overall cosmetic outcome 12 weeks after last PDT is calculated as difference between 12 weeks after PDT sum score and baseline sum score of all skin quality assessments. Each of the below skin quality characteristics are assessed on a 4-point scale from 0 (none) to 3 (severe) by the investigator at baseline and 12 weeks after last PDT:

* Skin surface
* Hyperpigmentation
* Hypopigmentation
* Mottled or irregular pigmentation
* Degree of scarring
* Atrophy

Cosmetic outcome categories are:

* Very good: 12 weeks sum score improved by at least 2 points compared to baseline
* Good: 12 weeks sum score improved by 1 point compared to baseline
* Satisfactory: 12 weeks sum score identical to the one at baseline
* Unsatisfactory: 12 weeks sum score worsened by 1 point compared to baseline
* Impaired: 12 weeks sum score worsened by at least 2 points compared to baseline

Accovion GmbH

Biofrontera Bioscience GmbH

Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU.

Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU.

Methyl-aminolevulinate

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Clinical Trial Department

Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations.

Overall Patient Complete Response Rate Assessed 12 Weeks After the Last PDT

Lesion Complete Response Assessed 12 Weeks After the Last PDT

Reduction of Lesion Area 12 Weeks After the Last PDT Compared to Baseline

Patient Complete Response 12 Weeks After PDT-2

Very good

Good

Satisfactory

Unsatisfactory

Impaired

Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline)

Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1)

Per protocol analysis set in the follow-up (PPS-FUP): all patients of the full analysis set in the follow-up (FAS-UP) without any major protocol deviations

Patient Recurrence Rate (Overall, Cumulative)

Overall

sBCC

nBCC

Per protocol analysis in follow-up (PPS-FUP): All lesions in patients in the full analysis set in follow-up (FAS-FUP) without any major protocol deviations

Lesion Recurrence Rate (Cumulative)

Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (all lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU.

Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (all lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU.

Spots Global Cancer Trial Database for Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial