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

Superficial Basal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325688
• Other study ID #: PEP005-037
• Status: Completed
• Phase: Phase 2
• First received: March 25, 2011
• Last updated: January 27, 2016
• Start date: April 2011
• Est. completion date: March 2012

Study information

• Verified date: January 2016
• Source: Peplin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell
• Superficial Basal Cell Carcinoma

Intervention

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

Device:
• Aluminium disk

• OpSite(TM) disk

Locations

Country	Name	City	State
Australia	The Skin Centre	Benowa	Queensland
Australia	Southderm Pty Ltd	Kogarah	New South Wales
Australia	St George Dermatology	Kogarah	New South Wales
Australia	Dermatology Institute of Victoria	South Yarra	Victoria
Australia	St John of God Dermatology	Subiaco	Western Australia
Australia	Burswood Dermatology	Victoria Park	Western Australia
Australia	Specialist Connect	Woolloongabba	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Peplin

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment related Adverse Events, Local Skin Responses; Pigmentation and scarring	Number of participants with treatment related Adverse Events, change from baseline in LSR and pigmentation and scarring.	120 days	Yes
Secondary	Histological and clinical clearance of sBCC lesions.	Number of participants with histological and clinical clearance of sBCC lesions.	120 days	No

External Links

•   FDA
•   Therapeutic Goods Administration