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

Actinic Keratosis Clinical Trial

Official title:

A 4-Day, Randomized, Controlled, Open Application Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers, Using a Phototoxicity Test Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850811
• Other study ID #: PEP005-023
• Status: Completed
• Phase: Phase 1
• First received: February 23, 2009
• Last updated: September 7, 2015
• Start date: February 2009
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: Peplin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• PEP005 (ingenol mebutate) Gel
PEP005 (ingenol mebutate) Gel, 0.01%

Locations

Country	Name	City	State
United States	TKL Research, Inc.	Paramus	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Peplin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the photoirritation potential of PEP005 Gel, when application is followed by light exposure.		4 days	Yes

External Links

•   Clinical Trials at LEO Pharma
•   Food and Drug Authority