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The purpose of this study is to determine if the new vehicle formulations containing ingenol mebutate are as safe and effective as Picato® gel 0.05% (it's current vehicle formulation) when applied to AK lesions on the forearm for two consecutive days.
This study will be run in 2 parts. The first part involves applying escalating concentrations of the new vehicle formulations containing ingenol mebutate to AKs on the forearms. Reactions and safety will be compared to Picato® (a registered and marketed ingenol mebutate gel) to ascertain if the new vehicle formulations are at least as safe and effective as Picato® . The purpose of part 2 is to select the concentration in the "new formulation" that produces this same, if not better response, as Picato® and with a similar or better safety profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Picato® 0.05% gel | Active Comparator | once daily for two consecutive days |
|
| ingenol mebutate vehicle formulation 1 | Experimental | once daily for two consecutive days |
|
| ingenol mebutate vehicle formulation 2 | Experimental | once daily for two consecutive days |
|
| ingenol mebutate vehicle formulation 3 | Experimental | once daily for two consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| once daily for two consecutive days (Picato) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of 3 new vehicle formulations containing ingenol mebutate compared to Picato® gel applied topically once daily for two consecutive days to four separate treatment areas containing actinic keratosis on the forearm | Safety data to be collected via CRF entries of AEs/SAEs and photographs. Relative skin reactions for comparison to Picato®. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate treatment responses on AK of selected concentration of ingenol mebutate containing vehicle formulation from Part 1 compared to Picato® gel as assessed by reduction in the number of selected AK lesions 2 months after treatment | Assessed by visible and imaged lesion count | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the new ingenol mebutate vehicle formulation (ascertained in Part 1) compared to Picato® gel applied topically once daily for 2 consecutive days to 4 separate treatment areas containing actinic keratosis on the forearm | Safety data to be collected via CRF entries of AEs/SAEs and photographs. Treatment responses assessed by Reflective confocal microscopy scoring of visible selected AK lesions | 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Department | Woolloongabba | Queensland | 4102 | Australia | ||
| Specialist Connect |
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| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
| Therapeutic Goods Administration | View source |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C486592 | 3-ingenyl angelate |
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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|
| Woolloongabba |
| Queensland |
| 4102 |
| Australia |
| D017437 |
| Skin and Connective Tissue Diseases |