The purpose of the study is to demonstrate that ingenol mebutate gel is efficacious in treating Actinic Keratoses (AKs) present 8 weeks after initial field treatment or emerging in a previously cleared field.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
463
Topical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015%
Topical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015%
St John of God Dermatology
Subiaco, Australia
Stratica Medical
Edmonton, Alberta, Canada
Skin Care Centre
Vancouver, British Columbia, Canada
Number of Participants With Complete Clearance of AKs 8 Weeks After Randomisation
The complete clearance rates 8 weeks after randomisation was compared between ingenol mebutate gel, 0.015% and vehicle gel. Complete clearance was defined as no clinically visible AKs in the Selected Treatment Area (STA)
Time frame: 8 weeks after randomisation
Number of Participants With Complete Clearance Through to Month 12, Defined as no Clinically Visible AKs and no Lesions Treated in the Selected Treatment Area at Any Time From Last Treatment Cycle Through to Month 12
The analysis was done separately for the field recalcitrant subgroup, the field recurrent subgroup, and overall for all treated subject (Analysis 1, 2, and 3, respectively)
Time frame: From last treatment cycle through to Month 12
The Change in AK Count From Randomisation to 8 Weeks After Randomisation
The change in AK count from randomisation to 8 weeks after randomisation was determined for the field recalcitrant and the field recurrent subgroups
Time frame: 8 weeks after randomisation
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Dermadvances Research
Winnipeg, Manitoba, Canada
Durondel C.P. Inc./Dermatology Clinic
Moncton, New Brunswick, Canada
UltraNova Skincare
Barrie, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
Windsor Clinical Research Inc.
Windsor, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
Centre de Recherche Dermatologique
Québec, Quebec, Canada
...and 3 more locations