PEP005 Gel - Evaluation of the Safety and Efficacy of Ingenol Mebutate Gel on a Superficial Basal Cell Carcinoma on the Trunk or Extremities

Study Overview
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Brief Summary
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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 superficial Basal Cell Carcinoma (sBCC) lesions on the trunk and extremities.

Official Title
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A Phase 2 Multi-centre, Parallel Group, Open Label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05%, When Administered for up to Three Consecutive Days to a Superficial Basal Cell Carcinoma (sBCC) on the Trunk or Extremities

Conditions
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Superficial Basal Cell Carcinoma

Intervention / Treatment
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* Drug: PEP005 (ingenol mebutate) Gel, 0.05%
* Device: Aluminium disk
* Device: OpSite(TM) disk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be male or female and at least 18 years of age Female patients must be of: non-childbearing potential or if of childbearing potential then have a negative serum and urine pregnancy test and using effective contraception Ability to provide informed consent primary diagnosed and histologically confirmed sBCC located on the trunk or extremities which is suitable for excision Exclusion Criteria: location of the sBCC lesion within 10cm of an incompletely healed wound, on the hand or foot, on the breast of women, on the anogenital area. Undergone cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to the screening visit. Use of acid-containing therapeutic products within 2 cm of the selected treatment area in the 2 weeks prior to the screening visit Use of topical moisturisers/creams/lotions (non-medicated/non-irritant salves are acceptable), artificial tanners or topical steroids: within 2 cm of the selected treatment area. Have received treatment with immunomodulators, or interferon/interferon inducers, systematic medications that suppress the immune system or UVB in the last 4 weeks Have undergone treatment with 5-FU, imiquimod, diclofenac or photodynamic therapy within 2 cm of the selected treatment area within 8 weeks prior to any screening visit. Use of systemic retinoids. Those who are currently participating in any other clinical trial Those known or suspected of not being able to comply with the requirements of the protocol Females who are pregnant or are breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>PEP005 0.05% gel applied and occluded with an aluminium disk for up to three consecutive days | Drug: PEP005 (ingenol mebutate) Gel, 0.05%<br>* PEP005 (ingenol mebutate) Gel, 0.05% for up to three consecutive days<br>Device: Aluminium disk<br> <br> |
| Experimental: Group 2<br>PEP005 0.05% Gel applied and occluded with an OpSite(TM) disk up to three consecutive days | Drug: PEP005 (ingenol mebutate) Gel, 0.05%<br>* PEP005 (ingenol mebutate) Gel, 0.05% for up to three consecutive days<br>Device: OpSite(TM) disk<br> <br> |
| Experimental: Group 3<br>PEP005 0.05% applied with no occlusion for up to three consecutive days | Drug: PEP005 (ingenol mebutate) Gel, 0.05%<br>* PEP005 (ingenol mebutate) Gel, 0.05% for up to three consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment related Adverse Events, Local Skin Responses; Pigmentation and scarring | Number of participants with treatment related Adverse Events, change from baseline in LSR and pigmentation and scarring. | 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological and clinical clearance of sBCC lesions. | Number of participants with histological and clinical clearance of sBCC lesions. | 120 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEP005, Peplin, sBCC