NCT01325688

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

February 26, 2016

Status Verified

January 1, 2016

Enrollment Period

11 months

First QC Date

March 25, 2011

Last Update Submit

January 27, 2016

Conditions

Superficial Basal Cell Carcinoma

Keywords

PEP005PeplinsBCC

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Histological and clinical clearance of sBCC lesions.

    120 days

Study Arms (3)

Group 1

EXPERIMENTAL

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

Drug: PEP005 (ingenol mebutate) Gel, 0.05%Device: Aluminium disk

Group 2

EXPERIMENTAL

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

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

Group 3

EXPERIMENTAL

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

Drug: PEP005 (ingenol mebutate) Gel, 0.05%

Interventions

PEP005 (ingenol mebutate) Gel, 0.05%DRUG

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

Group 1Group 2Group 3
Aluminium diskDEVICE
Group 1
OpSite(TM) diskDEVICE
Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Southderm Pty Ltd

Kogarah, New South Wales, 2217, Australia

Location

St George Dermatology

Kogarah, New South Wales, 2217, Australia

Location

The Skin Centre

Benowa, Queensland, 4217, Australia

Location

Specialist Connect

Woolloongabba, Queensland, 4102, Australia

Location

Dermatology Institute of Victoria

South Yarra, Victoria, 3141, Australia

Location

St John of God Dermatology

Subiaco, Western Australia, 6008, Australia

Location

Burswood Dermatology

Victoria Park, Western Australia, 6100, Australia

Location

Related Links

MeSH Terms

Interventions

3-ingenyl angelateGels

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Jacqueline Morley

    Peplin Operations

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2011

First Posted

March 30, 2011

Study Start

April 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

February 26, 2016

Record last verified: 2016-01

Locations

AU(7)