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

Phase 2

Completed

Interventions: Drug: PEP005 (ingenol mebutate) Gel, 0.05%
Device: Aluminium disk
Device: OpSite(TM) disk

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Group 3	PEP005 (ingenol mebutate) Gel, 0.05%	PEP005 0.05% applied with no occlusion for up to three consecutive days
Group 1	PEP005 (ingenol mebutate) Gel, 0.05%	PEP005 0.05% gel applied and occluded with an aluminium disk for up to three consecutive days
Group 1	Aluminium disk	PEP005 0.05% gel applied and occluded with an aluminium disk for up to three consecutive days
Group 2	PEP005 (ingenol mebutate) Gel, 0.05%	PEP005 0.05% Gel applied and occluded with an OpSite(TM) disk up to three consecutive days
Group 2	OpSite(TM) disk	PEP005 0.05% Gel applied and occluded with an OpSite(TM) disk up to three consecutive days

Primary Outcome Measures

Name	Time	Method
Treatment related Adverse Events, Local Skin Responses; Pigmentation and scarring	120 days	Number of participants with treatment related Adverse Events, change from baseline in LSR and pigmentation and scarring.

Secondary Outcome Measures

Name	Time	Method
Histological and clinical clearance of sBCC lesions.	120 days	Number of participants with histological and clinical clearance of sBCC lesions.

Locations (7): St John of God Dermatology
🇦🇺
Subiaco, Western Australia, Australia
Burswood Dermatology
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Victoria Park, Western Australia, Australia
Specialist Connect
🇦🇺
Woolloongabba, Queensland, Australia
The Skin Centre
🇦🇺
Benowa, Queensland, Australia
St George Dermatology
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Kogarah, New South Wales, Australia
Southderm Pty Ltd
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Kogarah, New South Wales, Australia
Dermatology Institute of Victoria
🇦🇺
South Yarra, Victoria, Australia