Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01926496|
Recruitment Status : Completed
First Posted : August 21, 2013
Last Update Posted : September 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Actinic Keratosis (AK)||Drug: Ingenol Mebutate Gel, 0.015% Drug: Imiquimod Cream, 5%||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||579 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 4 Trial Comparing the Cumulative Incidence of SCC After Treatment With Ingenol Mebutate and Imiquimod for Multiple Actinic Keratoses on Face and Scalp. A Multi-centre, Randomised, Two-arm, Open Label, Active-controlled, Parallel Group, 36-month Trial|
|Actual Study Start Date :||September 11, 2013|
|Actual Primary Completion Date :||July 11, 2019|
|Actual Study Completion Date :||July 11, 2019|
Experimental: Ingenol Mebutate
Arm A: Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8
Drug: Ingenol Mebutate Gel, 0.015%
Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.
Other Name: Picato®
Active Comparator: Imiquimod
Arm B: Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8
Drug: Imiquimod Cream, 5%
Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs
Other Name: Aldara®
- Incidence of SCC [ Time Frame: 3 years ]
To compare the cumulative incidence of SCC after treatment with ingenol mebutate gel and imiquimod cream.
The primary response criterion is diagnosis of SCC (defined as invasive SCC i.e. excludes SCC in situ) in the treatment field across the 3-year trial period.
- Incidence of neoplasia [ Time Frame: 12 months ]To compare the cumulative incidence of neoplasia and the short-term and 12-month efficacy of ingenol mebutate gel with imiquimod cream.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926496
Show 46 Study Locations
|Principal Investigator:||Rolf-Markus Szeimies, Prof.Dr.med.||Klinik für Dermatologie und Allergologie|