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

Seborrheic Keratosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214564
• Other study ID #: PEP005-033
• Status: Completed
• Phase: Phase 2
• First received: October 3, 2010
• Last updated: January 23, 2011
• Start date: October 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: Peplin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Keratosis
• Keratosis, Actinic
• Keratosis, Seborrheic
• Seborrheic Keratosis

Intervention

Drug:
• PEP005 (ingenol mebutate) Gel
0.05%

Locations

Country	Name	City	State
Australia	Southderm Pty Ltd	Kogarah	New South Wales
Australia	Specialist Connect	Woolloongabba	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Peplin

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No

External Links

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