Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.015%, in Patients With Photo-damaged Skin

Photo-damage Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214577
• Other study ID #: PEP005-036
• Status: Completed
• Phase: Phase 2
• First received: October 3, 2010
• Last updated: January 23, 2011
• Start date: October 2010
• Est. completion date: January 2011

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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.

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

• Photo-damage

Intervention

Drug:
• PEP005 (ingenol mebutate) Gel
0.015%

Locations

Country	Name	City	State
Australia	The Skin Centre	Benowa	Queensland
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, 0.015% when administered for up to three consecutive days to photo-damaged skin on the face.		Day 43	Yes
Secondary	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.		Day 43	No

External Links

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