PMS to Evaluate the Safety and Efficacy of Picato® Gel
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Seoul, Korea, Republiken av
- Department of Dermatology, Korea University Anam Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
Adult patient with AK First time treatment with ingenol mebutate 0.015 or 0.05 percent gel
Exclusion Criteria:
- Children and adolescents
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Ingenol mebutate treatment cohort
Patients who are prescribed ingenol mebutate gel for the first time by investigator's medical judgment.
|
Topical treatment with ingenol mebutate gel 0.015 percent or 0.05 percent gel of skin areas affected by AK
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Adverse Events
Tidsram: 8 weeks after treatment completion
|
According to Korean definition and classification, covering serious as well as non-serious Adverse Events, related as well as non-related to ingenol mebutate treatment
|
8 weeks after treatment completion
|
|
Overall improvement
Tidsram: 8 weeks after treatment completion
|
Graded by investigator on a 3-point scale ('improved', 'no change', 'worsened'), based on number of AK lesions in treated area compared to baseline
|
8 weeks after treatment completion
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Complete clearance rate - Change in AK lesions count: Percentage (%) change in the total number of AK lesions compared to baseline*
Tidsram: 8 weeks after treatment
|
Proportion of patients with no clinically visible AK lesions in treated area
|
8 weeks after treatment
|
|
Partial clearance rate
Tidsram: 8 weeks after treatment
|
Proportion of patients with 75% or greater reduction in the number of AK lesions in treated area compared to baseline
|
8 weeks after treatment
|
|
Change in AK lesion count
Tidsram: 8 weeks after treatment
|
Percentage change in the total number of AK lesions in treated area compared to baseline
|
8 weeks after treatment
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Sun Choi, B.Sc., LEO Pharma Limited, Korea
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NIS-PICATO-1130
Plan för individuella deltagardata (IPD)
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