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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01325688




Registration number
NCT01325688
Ethics application status
Date submitted
25/03/2011
Date registered
30/03/2011
Date last updated
26/02/2016

Titles & IDs
Public title
PEP005 Gel - Evaluation of the Safety and Efficacy of Ingenol Mebutate Gel on a Superficial Basal Cell Carcinoma on the Trunk or Extremities
Scientific 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
Secondary ID [1] 0 0
PEP005-037
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Superficial Basal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PEP005 (ingenol mebutate) Gel, 0.05%
Treatment: Devices - Aluminium disk
Treatment: Devices - OpSite(TM) disk

Experimental: Group 1 - PEP005 0.05% gel applied and occluded with an aluminium disk for up to three consecutive days

Experimental: Group 2 - PEP005 0.05% Gel applied and occluded with an OpSite(TM) disk up to three consecutive days

Experimental: Group 3 - PEP005 0.05% applied with no occlusion for up to three consecutive days


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

Treatment: Devices: Aluminium disk


Treatment: Devices: OpSite(TM) disk
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment related Adverse Events, Local Skin Responses; Pigmentation and scarring
Timepoint [1] 0 0
120 days
Secondary outcome [1] 0 0
Histological and clinical clearance of sBCC lesions.
Timepoint [1] 0 0
120 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2012
Sample size
Target
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Southderm Pty Ltd - Kogarah
Recruitment hospital [2] 0 0
St George Dermatology - Kogarah
Recruitment hospital [3] 0 0
The Skin Centre - Benowa
Recruitment hospital [4] 0 0
Specialist Connect - Woolloongabba
Recruitment hospital [5] 0 0
Dermatology Institute of Victoria - South Yarra
Recruitment hospital [6] 0 0
St John of God Dermatology - Subiaco
Recruitment hospital [7] 0 0
Burswood Dermatology - Victoria Park
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4217 - Benowa
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3141 - South Yarra
Recruitment postcode(s) [5] 0 0
6008 - Subiaco
Recruitment postcode(s) [6] 0 0
6100 - Victoria Park

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Peplin
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01325688
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jacqueline Morley
Address 0 0
Peplin Operations
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01325688