Study to Evaluate the Safety and Efficacy of PEP005 (Inge... | NCT01214577

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

NCT01214577

Sponsor

Peplin

Status

Completed

Last Update Posted

Jan 25, 2011Estimated

Enrollment

24Actual

Phase

Phase 2

Conditions

Photo-damage

Interventions

PEP005 (ingenol mebutate) Gel

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Oct 3, 2010

First Submission Date that Met QC Criteria

Oct 3, 2010

First Posted Date

Oct 5, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2011

Last Update Posted Date

Jan 25, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Up to three days of treatment	Drug: PEP005 (ingenol mebutate) Gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PEP005 (ingenol mebutate) Gel	Drug	0.015%	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Male and female patients aged 30 to 65 years.
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.
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.
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

Known sensitivity or allergy to any of the ingredients in PEP005 (ingenol mebutate) Gel.
Current enrolment or participation in a clinical research study within 30 days of entry into this study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
The Skin Centre		Benowa	Queensland	4217	Australia
Specialist Connect

Label	URL
Related Info	View source

Intervention Browse Module

MeSH Terms

ID	Term
C486592	3-ingenyl angelate
D005782	Gels

Ancestor Terms

ID	Term
D003102	Colloids
D045424	Complex Mixtures
D004304	Dosage Forms
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided