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A Phase 2a, Multi-Centre, Open-Label Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis on Non-head Locations


Phase 2
18 Years
N/A
Not Enrolling
Both
Seborrheic Keratosis

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Trial Information

A Phase 2a, Multi-Centre, Open-Label Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis on Non-head Locations

Inclusion Criteria


Inclusion Criteria

1. Patient is male or female and at least 18 years of age.

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 lesions to be taken
and used as part of the study data package.

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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.

Outcome Time Frame:

Day 43

Safety Issue:

Yes

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

PEP005-033

NCT ID:

NCT01214564

Start Date:

October 2010

Completion Date:

December 2010

Related Keywords:

  • Seborrheic Keratosis
  • PEP005
  • Peplin
  • Seborrhoeic Keratosis
  • Keratosis
  • Keratosis, Actinic
  • Keratosis, Seborrheic

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