Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis

NCT01214564 — Phase 2, Completed, 24 participants, Peplin

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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

Registry	NCT01214564
Status	Completed
Phase	Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	24 (Actual)
Sponsor	Peplin (Industry)
Conditions	Seborrheic Keratosis
Interventions	PEP005 (ingenol mebutate) Gel (Drug)
Dates	start 2010-10-01, primary completion 2010-12-01, completion 2010-12-01, first posted 2010-10-05, last updated 2011-01-25
Locations	2 sites in Australia

-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 Seborrhoeic Keratosis on non-head locations. The secondary endpoint is to investigate the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.

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+Arms and interventions

Arm	Type	Interventions	Description
1	Experimental	Drug: PEP005 (ingenol mebutate) Gel	Up to three days of treatment

PEP005 (ingenol mebutate) Gel (Drug): 0.05%

+Outcome measures

Primary outcomes

To evaluate the safety of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations. [Day 43]

Secondary outcomes

To determine the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations. [Day 43]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (2)

Facility	City	Country	Status
Southderm Pty Ltd	Kogarah, New South Wales	Australia
Specialist Connect	Woolloongabba, Queensland	Australia