Clinical trial NCT01325688: PEP005 Gel - Evaluation of the Safety and Efficacy of Ingenol Mebutate Gel on a Superficial Basal Cell Carcinoma on the Trunk or Extremities
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Superficial Basal Cell Carcinoma
Keywords: PEP005
Peplin
sBCC
Lead sponsor: Peplin
Sponsor class: INDUSTRY
First posted: 2011-03-30
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Treatment related Adverse Events, Local Skin Responses; Pigmentation and scarring
timeFrame: 120 days
Secondary outcomes:
measure: Histological and clinical clearance of sBCC lesions.
timeFrame: 120 days
Other outcomes:
Locations:
city: Kogarah
country: Australia
facility: Southderm Pty Ltd
state: New South Wales
city: Kogarah
country: Australia
facility: St George Dermatology
state: New South Wales
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: Woolloongabba
country: Australia
facility: Specialist Connect
state: Queensland
city: South Yarra
country: Australia
facility: Dermatology Institute of Victoria
state: Victoria
city: Subiaco
country: Australia
facility: St John of God Dermatology
state: Western Australia
city: Victoria Park
country: Australia
facility: Burswood Dermatology
state: Western Australia
Study officials:
affiliation: Peplin Operations
name: Jacqueline Morley
role: STUDY_DIRECTOR
References: