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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01325688

Enrollment

Registered

2011-03-30

Start date

2011-04-30

Completion date

2012-03-31

Last updated

2016-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Superficial Basal Cell Carcinoma

Keywords

PEP005, Peplin, sBCC

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.

Interventions

DRUGPEP005 (ingenol mebutate) Gel, 0.05%

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

DEVICEAluminium disk

DEVICEOpSite(TM) disk

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Histological and clinical clearance of sBCC lesions.	120 days	Number of participants with histological and clinical clearance of sBCC lesions.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026