Phase 3
Completed N=87
Safety and Efficacy Study for the Field-directed Treatment of Actinic Keratosis (AK) With Photodynamic Therapy (PDT)
Source: ClinicalTrials.gov NCT01966120 ↗Enrolled (actual)
87
Serious AEs
2.3%
Results posted
Dec 2016
Primary outcomePrimary: Overall Patient Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) — 90.9; 21.9 percentage of participants
◆ Published Evidence
Emerging
6citations · ~6 / year
Long-term follow-up of a randomized, double-blind, phase III, multi-centre study to evaluate the safety and efficacy of field-directed photodynamic therapy (PDT) of mild to moderate actinic keratosis using BF-200 ALA versus placebo and the BF-RhodoLED® lamp.
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.
Linked Publications
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Long-term follow-up of a randomized, double-blind, phase III, multi-centre study to evaluate the safety and efficacy of field-directed photodynamic therapy (PDT) of mild to moderate actinic keratosis using BF-200 ALA versus placebo and the BF-RhodoLED® lamp.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Patient Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) |
90.9; 21.9 | — |
| PRIMARY Overall Patient Complete Response 12 Weeks After the Last PDT (PP) |
90.0; 25.9 | — |
| SECONDARY Patient Histopathological Confirmed Response Rate |
77.8; 22.2 | — |
| SECONDARY Patient Complete Response 12 Weeks After PDT 1 |
61.8; 9.4 | — |
| SECONDARY Lesion Complete Response 12 Weeks After Last PDT |
94.3; 32.9 | — |
| SECONDARY Patient Partial Response 12 Weeks After Last PDT |
94.5; 25 | — |
| SECONDARY Change of Total Lesion Area 12 Weeks After Last PDT |
-98.2; -45.5 | — |
| SECONDARY Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 0 to 3 |
35.2; 17.2; 24.1; 13.8; 24.1; 20.7 | — |
| SECONDARY Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 1 to 3 |
39.6; 19.2; 27.1; 15.4; 22.9; 23.1 | — |
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
Data sourced from ClinicalTrials.gov (NCT01966120) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.