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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peplin

Criteria

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