Actinic Keratosis Clinical Trial
Official title:
Post-Marketing Surveillance to Evaluate the Safety and Efficacy of Picato® Gel
This study is a mandatory post launch observational study in South Korea of 3.000 patients
receiving treatment for the first time with a new medicinal product, ingenol mebutate gel
(Picato®), approved for topical treatment of actinic keratosis.
Each patient is observed for 8 weeks after treatment completion.
Picato® (ingenol mebutate) gel is a new topical therapy for Actinic Keratosis (AK) in adults
which was approved by the Korean Ministry of Food and Drug Safety (MFDS) in December 2013.
For AK in face or scalp the 0.015 percent gel is approved to be applied once a day for 3
consecutive days, and for AK in trunk or extremities the 0.05 percent gel is approved to be
applied once a day for 2 consecutive days.
The re-examination period for Picato® runs from December 2013 to December 2019, during which
at least 3,000 patients who are prescribed ingenol mebutate gel for the first time by
investigator's medical judgment must be documented in a standard Post Marketing Surveillance
(PMS) study.
Each patient is to be observed for 8 weeks following application of ingenol mebutate gel. If
a patient is unable to visit the PMS site, the investigator may contact the patient by phone
to assess the safety.
;
| 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 |
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 | |
| Terminated |
NCT01525329 -
Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease
|
Phase 3 | |
| Completed |
NCT01449513 -
PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy
|
Phase 1 | |
| Completed |
NCT01444989 -
Development and Validation of a Quality of Life Instrument for Actinic Keratosis
|
N/A | |
| 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 |
NCT02878382 -
Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT
|
N/A | |
| Completed |
NCT02938715 -
Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil
|
N/A | |
| Completed |
NCT02902822 -
Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo
|
N/A |