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A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations
Phase 3
Waitlist Available
Research Sponsored by Peplin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 57 days
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Summary
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
Eligible Conditions
- Actinic Keratosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 57 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~57 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions
Secondary study objectives
Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: PEP005 (ingenol mebutate) GelActive Control1 Intervention
PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
Group II: Vehicle gelPlacebo Group1 Intervention
Vehicle gel once daily for 2 consecutive days
Find a Location
Who is running the clinical trial?
PeplinLead Sponsor
28 Previous Clinical Trials
2,635 Total Patients Enrolled