Actinic Keratosis Clinical Trial
Official title:
A Randomized Placebo-controlled Clinical Trial of Topical Photodynamic Therapy With 5-aminolevulinic Acid for the Treatment of Actinic Keratosis
This was a placebo controlled, double blind, randomized phase II dose-response study to evaluate the efficacy and safety of BF-200 ALA (containing the active ingredient 5 - aminolevulinic acid- ALA) used with photodynamic therapy (PDT) in patients with actinic keratosis (AK).
The study was performed to define the effective therapeutic dose of the active
pharmaceutical ingredient (ALA) in a nanoemulsion formulation in the treatment of actinic
keratosis (AK) with topical PDT and to assess the efficacy of topical PDT with a new
nanoemulsion formulation of ALA in the treatment of AK. The efficacy of BF-200 ALA was
calculated by the AK clearance rate, defined as the proportion of AK lesions showing
complete remission 12 weeks after PDT treatment.
Subjects of two study centres provided plasma and urine samples for the quantification of
ALA and its metabolite, the active photosensitizer protoporphyrin IX (PpIX).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03013647 -
Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization
|
N/A | |
| Completed |
NCT02674048 -
Metvix Daylight PDT in Actinic Keratosis
|
||
| Completed |
NCT02421471 -
PMS to Evaluate the Safety and Efficacy of Picato® Gel
|
||
| Completed |
NCT02239679 -
Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy
|
Phase 2 | |
| Completed |
NCT01686152 -
Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis
|
Phase 3 | |
| Completed |
NCT01444989 -
Development and Validation of a Quality of Life Instrument for Actinic Keratosis
|
N/A | |
| Completed |
NCT01449513 -
PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy
|
Phase 1 | |
| Terminated |
NCT01525329 -
Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease
|
Phase 3 | |
| Terminated |
NCT01203878 -
Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy
|
Phase 4 | |
| Completed |
NCT00989313 -
A Long Term Follow up Study of Patients Who Have Complete Clearance of Their Actinic Keratosis (AK) Lesions at the Day 57 Visit in the PEP005-028 Study
|
Phase 3 | |
| Completed |
NCT00306800 -
Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp
|
Phase 3 | |
| Completed |
NCT00375739 -
Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses
|
Phase 2 | |
| Completed |
NCT03285490 -
A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)
|
Phase 3 | |
| Completed |
NCT03319251 -
Biomarker Database Registry for Photodynamic Therapy
|
||
| Completed |
NCT02866695 -
Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients
|
Phase 4 | |
| Completed |
NCT02952898 -
Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses
|
Phase 3 | |
| Completed |
NCT02984072 -
Menthol for PDT Pain Relief
|
Phase 4 | |
| Recruiting |
NCT03684772 -
Topical Ionic Contra-Viral Therapy in Actinic Keratosis
|
Phase 2 | |
| Completed |
NCT02902822 -
Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo
|
N/A | |
| Completed |
NCT02878382 -
Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT
|
N/A |