Trial Review

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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/NCT01214577




Registration number
NCT01214577
Ethics application status
Date submitted
3/10/2010
Date registered
5/10/2010
Date last updated
25/01/2011

Titles & IDs
Public title
Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.015%, in Patients With Photo-damaged Skin
Scientific title
A Phase 2a, Multi-Centre, Single Arm Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.015%, in Patients With Photo-damaged Skin on the Face
Secondary ID [1] 0 0
PEP005-036
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Photo-damage 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PEP005 (ingenol mebutate) Gel

Experimental: 1 - Up to three days of treatment


Treatment: Drugs: PEP005 (ingenol mebutate) Gel
0.015%
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety of PEP005 Gel, 0.015% when administered for up to three consecutive days to photo-damaged skin on the face.
Timepoint [1] 0 0
Day 43
Secondary outcome [1] 0 0
To determine the efficacy of PEP005 Gel, 0.015% when administered for up to three consecutive days in patients with photo-damaged skin on the face.
Timepoint [1] 0 0
Day 43

Eligibility
Key inclusion criteria
Inclusion Criteria

1. Male and female patients aged 30 to 65 years.

2. Female patients must be of either:

- Non-childbearing potential, provided there is a laboratory confirmed serum
follicle stimulating hormone (FSH) level = 40mIU/ml or there is a confirmed
clinical history of sterility (e.g., the patient is without a uterus); or

- Childbearing potential, provided there are negative urine pregnancy test results
prior to study treatment, to rule out pregnancy.

3. Patient has provided informed consent documented by signing the Informed Consent Form
(ICF) prior to any study-related procedures, including any alteration of medications
in preparation for study entry.

4. Patient has agreed to allow photographs of the selected treatment area to be taken and
used as part of the study data package.
Minimum age
30 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. Known sensitivity or allergy to any of the ingredients in PEP005 (ingenol mebutate)
Gel.

2. Current enrolment or participation in a clinical research study within 30 days of
entry into this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
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
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2011
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
The Skin Centre - Benowa
Recruitment hospital [2] 0 0
Specialist Connect - Woolloongabba
Recruitment postcode(s) [1] 0 0
4217 - Benowa
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba

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 evaluate the safety and tolerability of PEP005 Gel,
0.015% when administered for up to three consecutive days to photo-damaged skin on the face.
The secondary endpoint is to determine the efficacy of PEP005 Gel, 0.015% when administered
for up to three consecutive days in patients with photo-damaged skin on the face.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01214577
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT01214577