Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest
- Registration Number
- NCT02361216
- Lead Sponsor
- LEO Pharma
- Brief Summary
The objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for actinic keratosis applied to large treatment areas once daily for three consecutive days on face, scalp or chest.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 729
Subjects with 5 to 20 clinically typical, visible and discrete, actinic keratosis (AKs) non-hyperkeratotic and non-hypertrophic AKs within a selected treatment area of sun-damaged skin on either:
- The full face
- The full balding scalp
- A contiguous area of approximately 250 cm2 on the chest
- Location of the treatment area (full face, full balding scalp or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).
- Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO clinical programme on ingenol mebutate gel for larger treatment areas.
- Treatment with ingenol mebutate gel in the selected treatment area within the last 12 months.
- Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horn) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ingenol mebutate gel Ingenol Mebutate Treatment once daily for 3 days Vehicle Vehicle Treatment once daily for 3 days
- Primary Outcome Measures
Name Time Method Percentage of Participants With Complete Resolution of Actinic Keratosis (AK) 8 weeks Complete resolution of actinic keratosis (AKclear100) at Week 8 is defined as 100% reduction from baseline in the number of clinically visible AKs
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Partial Clearance at Week 4 4 weeks Partial clearance (AKclear75) defined as a reduction in the number of clinically visible AKs in the selected treatment area by at least 75% compared to baseline.
Percent Reduction From Baseline in AK Count 8 weeks Percent reduction in AK count in the selected treatment area at Week 8
Percentage of Participants With Partial Clearance at Week 8 8 weeks Partial clearance (AKclear75 ) is defined as a reduction in the number of clinically visible AKs in the selected treatment area by at least 75% compared to baseline.
Trial Locations
- Locations (1)
Laser & Skin Surgery Center of Indiana
🇺🇸Carmel, Indiana, United States