Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is primarily designed to investigate whether treatment, once daily for up to three consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in patients with Seborrhoeic Keratosis on non-head locations. The secondary endpoint is to investigate the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Up to three days of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEP005 (ingenol mebutate) Gel | Drug | 0.05% |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations. | Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations. | Day 43 |
Not provided
Inclusion Criteria
Patient is male or female and at least 18 years of age.
Female patients must be of either:
Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures, including any alteration of medications in preparation for study entry.
Patient has agreed to allow photographs of the selected treatment lesions to be taken and used as part of the study data package.
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southderm Pty Ltd | Kogarah | New South Wales | 2217 | Australia | ||
| Specialist Connect |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D017492 | Keratosis, Seborrheic |
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011230 | Precancerous Conditions |
Not provided
Not provided
| ID | Term |
|---|---|
| C486592 | 3-ingenyl angelate |
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Woolloongabba |
| Queensland |
| 4102 |
| Australia |
| D009369 |
| Neoplasms |