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

Peplin

Status and phase: Completed; Phase 2

Conditions: Superficial Basal Cell Carcinoma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01325688

PEP005-037

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

75 participants in 3 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Device: Aluminium disk

Drug: PEP005 (ingenol mebutate) Gel, 0.05%

Group 2

Experimental group

Description:

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

Treatment:

Device: OpSite(TM) disk

Drug: PEP005 (ingenol mebutate) Gel, 0.05%

Group 3

Experimental group

Description:

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

Treatment:

Drug: PEP005 (ingenol mebutate) Gel, 0.05%