Clinical trial NCT01966120: Safety and Efficacy Study for the Field-directed Treatment of Actinic Keratosis (AK) With Photodynamic Therapy (PDT)
Official title: A Randomized, Double-blind, Phase III, Multi-center Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) Versus Placebo in the Field-directed Treatment of Mild to Moderate Actinic Keratosis With Photodynamic Therapy (PDT) When Using the BF-RhodoLED® Lamp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Keywords: Photodynamic Therapy
Field-directed Treatment
Lead sponsor: Biofrontera Bioscience GmbH
Sponsor class: INDUSTRY
First posted: 2013-10-21
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of BF-200 ALA (Ameluz) versus placebo in the field-directed treatment of mild to moderate actinic keratosis with photodynamic therapy (PDT) when using the BF-RhodoLED lamp.

Detailed description: The study was performed as a randomized, multicentre, double-blind, placebo- controlled, parallel-group, phase III trial with BF-200 ALA and placebo in seven centres in Germany. A total of 94 patients were screened in this study; 87 were randomized (55 patients received BF-200 ALA, 32 received placebo). Patients received one PDT. If residual lesions remained at 3 months after treatment, PDT was repeated. Illumination was performed with the PDT lamp BF-RhodoLED.

Eligibility criteria: Inclusion Criteria:

* Males or females between 18 and 85 years of age (inclusive)
* Presence of 4 to 8 clinically confirmed actinic keratosis (AK) target lesions of mild to moderate intensity within 1-2 fields

Exclusion Criteria:

* History of hypersensitivity to 5-ALA or any ingredient of BF-200 ALA
* Current treatment with immunosuppressive therapy
* Presence of other malignant or benign tumors of the skin within the treatment area (eg malignant melanoma, basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)) within the last 4 weeks
* Confirmed diagnosis of SCC for the representative lesion by screening biopsy

Primary outcomes:
measure: Overall Patient Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT)
timeFrame: 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT
measure: Overall Patient Complete Response 12 Weeks After the Last PDT (PP)
timeFrame: 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT
Secondary outcomes:
measure: Patient Histopathological Confirmed Response Rate
timeFrame: 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT
measure: Patient Complete Response 12 Weeks After PDT 1
timeFrame: 12 weeks after PDT 1
measure: Lesion Complete Response 12 Weeks After Last PDT
timeFrame: 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT
measure: Patient Partial Response 12 Weeks After Last PDT
timeFrame: 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT
measure: Change of Total Lesion Area 12 Weeks After Last PDT
timeFrame: 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT
measure: Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 0 to 3
timeFrame: 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT
measure: Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 1 to 3
timeFrame: 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT
Other outcomes:
measure: Patient Recurrence Rate in Follow-up (Cumulative)
timeFrame: 12 months after last treatment (PDT-1 or PDT-2, if re-treated)
measure: Lesion Recurrence Rate in Follow-up (Cumulative)
timeFrame: 12 months after last treatment (PDT-1 or PDT-2, if retreated)
measure: Skin Quality in Follow-up (6 Months)
timeFrame: 6 months after last treatment (PDT-1 or PDT-2, if re-treated)
measure: Skin Quality in Follow-up (12 Months)
timeFrame: 12 months after last treatment (PDT-1 or PDT-2, if re-treated)
measure: Patients' Satisfaction in Follow-up (6 Months)
timeFrame: 6 months after last treatment (PDT-1 or PDT-2, if re-treated)
measure: Patients' Satisfaction in Follow-up (12 Months)
timeFrame: 12 months after last treatment (PDT-1 or PDT-2, if re-treated)
Locations:
city: Bonn
country: Germany
facility: Dermatologisches Zentrum Bonn Friedensplatz
Study officials:
affiliation: Dermatologisches Zentrum Bonn
name: Uwe Reinhold, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: