Study to Determine the Safety of Two Applications of PEP0... | NCT00107965

Studies
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses

NCT00107965

Sponsor

Peplin

Status

Completed

Last Update Posted

Mar 25, 2015Estimated

Enrollment

Phase

Phase 2

Conditions

Actinic Keratosis

Interventions

PEP005
PEP005
PEP005
PEP005
PEP005
PEP005
PEP005
PEP005

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

ID	Type	Description	Link
2005/145

Status Module

Record Verification Date

Mar 2015

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

Mar 2005

Primary Completion Date

Sep 2005Actual

Completion Date

Sep 2005Actual

First Submitted Date

Apr 11, 2005

First Submission Date that Met QC Criteria

Apr 11, 2005

First Posted Date

Apr 12, 2005Estimated

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

Mar 24, 2015

Last Update Posted Date

Mar 25, 2015Estimated

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

Label	Type	Intervention Names
1	Experimental	Drug: PEP005
2	Experimental	Drug: PEP005
3	Experimental	Drug: PEP005
4	Placebo Comparator	Drug: PEP005
5	Experimental	Drug: PEP005
6	Experimental	Drug: PEP005
7	Experimental	Drug: PEP005
8	Placebo Comparator

Name	Type	Description	Arm Group Labels	Other Names
PEP005	Drug	0.0025% PEP005 Topical Gel (Day 1,2 application)	1
PEP005

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the safety of PEP005 Topical Gel at 0.0025%, 0.01%, and 0.05% administered as two applications to patients with actinic keratosis (AKs) on the arms, shoulders, chest, face, and/or scalp		85 days

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the efficacy of PEP005 0.0025%, 0.01% and 0.05% Topical Gel in treating Actinic Keratoses		85 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patients
At least five individual AK lesions on the arms, shoulders, chest, face and/or scalp

Exclusion Criteria:

A cosmetic or therapeutic procedure:
- within 10 cm of the selected AK lesions during the 3 months prior to study entry or
- anywhere during the 4 weeks prior to study entry or anticipated treatment during the study
Treatment with 5-fluorouracil, imiquimod, diclofenac or photodynamic therapy:
- of lesions located within 10 cm of the selected AK lesions during the 3 months prior to study entry or
- anywhere during the 4 weeks prior to study entry or anticipated treatment during the study
Use of acid-containing products, topical retinoids or light chemical peels within 10 cm of the selected AK lesions during the 3 months prior to study entry, or anticipated treatment in this same area during the study
Treatment with immuno-modulators, cytotoxic drugs, or interferon/interferon inducers during the 4 weeks prior to study entry or anticipated treatment during the study
Treatment with psoralen plus UVA or use of UVB therapy during the 6 months prior to study entry or anticipated treatment during the study
Use of systemic retinoids during the 6 months prior to study entry or anticipated treatment during the study
Anticipated excessive or prolonged exposure to ultraviolet light or use of topical salves, creams or ointments to the selected AK lesions during the study
Females of childbearing potential

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Royal Prince Alfred Hospital		Sydney	New South Wales	2050	Australia
Siller Medical

ID	Term
D055623	Keratosis, Actinic
D008548	Melanosis

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D007642	Keratosis
D012871	Skin Diseases