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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-03-31

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.

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Detailed Description

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Conditions

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Superficial Basal Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

PEP005 0.05% gel applied and occluded with an aluminium disk for up to three consecutive days

Group Type EXPERIMENTAL

PEP005 (ingenol mebutate) Gel, 0.05%

Intervention Type DRUG

PEP005 (ingenol mebutate) Gel, 0.05% for up to three consecutive days

Aluminium disk

Intervention Type DEVICE

Group 2

PEP005 0.05% Gel applied and occluded with an OpSite(TM) disk up to three consecutive days

Group Type EXPERIMENTAL

PEP005 (ingenol mebutate) Gel, 0.05%

Intervention Type DRUG

PEP005 (ingenol mebutate) Gel, 0.05% for up to three consecutive days

OpSite(TM) disk

Intervention Type DEVICE

Group 3

PEP005 0.05% applied with no occlusion for up to three consecutive days

Group Type EXPERIMENTAL

PEP005 (ingenol mebutate) Gel, 0.05%

Intervention Type DRUG

PEP005 (ingenol mebutate) Gel, 0.05% for up to three consecutive days

Interventions

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PEP005 (ingenol mebutate) Gel, 0.05%

PEP005 (ingenol mebutate) Gel, 0.05% for up to three consecutive days

Intervention Type DRUG

Aluminium disk

Intervention Type DEVICE

OpSite(TM) disk

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No