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

This study has been completed.
Sponsor:
Information provided by:
Peplin
ClinicalTrials.gov Identifier:
NCT01214564
First received: October 3, 2010
Last updated: January 23, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Seborrheic Keratosis
 Drug: PEP005 (ingenol mebutate) Gel
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peplin:

Primary Outcome Measures:
  • To evaluate the safety of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations. [ Time Frame: Day 43 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations. [ Time Frame: Day 43 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: October 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Up to three days of treatment
 Drug: PEP005 (ingenol mebutate) Gel
0.05%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01214564

Locations
Australia, New South Wales
Southderm Pty Ltd
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
Specialist Connect
Woolloongabba, Queensland, Australia, 4102
Sponsors and Collaborators
Peplin
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jacqueline Morley, Clinical Research Team Leader, Peplin
ClinicalTrials.gov Identifier: NCT01214564     History of Changes
Other Study ID Numbers: PEP005-033
Study First Received: October 3, 2010
Last Updated: January 23, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Peplin:
PEP005
Peplin
Seborrhoeic Keratosis

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Keratosis, Seborrheic
 Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013