A Study to Evaluate the Photoirritation Potential of PEP0... | NCT00850811

Studies
A Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers

NCT00850811

Sponsor

Peplin

Status

Completed

Last Update Posted

Sep 9, 2015Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Actinic Keratosis

Interventions

PEP005 (ingenol mebutate) Gel

Countries

United States

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

Apr 2009

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

Feb 2009

Primary Completion Date

Apr 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Feb 23, 2009

First Submission Date that Met QC Criteria

Feb 24, 2009

First Posted Date

Feb 25, 2009Estimated

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

Sep 7, 2015

Last Update Posted Date

Sep 9, 2015Estimated

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 Phase 1 study is designed to determine the photoirritation potential of PEP005 Gel, 0.01% when application is followed by light exposure.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: PEP005 (ingenol mebutate) Gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PEP005 (ingenol mebutate) Gel	Drug	PEP005 (ingenol mebutate) Gel, 0.01%	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the photoirritation potential of PEP005 Gel, when application is followed by light exposure.		4 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy males or females;
in the case of females of childbearing potential, must be using effective contraception and must provide a negative pregnancy test;
must read, understand and provide signed informed consent.

Exclusion Criteria:

are not willing to refrain from using topical/systemic analgesics within 72 hours prior to and during the study;
are using systemic/locally-acting medications during the study and within 2 weeks prior to the beginning of the study;
are using systemic/locally-acting anti-inflammatories during the study and within 72 hours prior to the beginning of the study;
have participated in any clinical testing of an investigational drug within 28 days or any clinical patch application within 14 days prior to enrollment or are currently participating in any clinical testing.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jonothan S Dosik, MD	TKL Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
TKL Research, Inc.		Paramus	New Jersey	07652	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24765228	Derived	Dosik JS, Damstra M, Udell C, Welburn P. Evaluation of the skin sensitization, photoirritation, and photoallergic potential of ingenol mebutate gel in healthy volunteers. J Clin Aesthet Dermatol. 2014 Apr;7(4):35-42.

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

ID	Term
C486592	3-ingenyl angelate
D005782	Gels

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