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A Randomized, Controlled Study to Evaluate the Photoallergic Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers Using an Open Application Photoallergic Test Design


Phase 1
18 Years
65 Years
Not Enrolling
Both
Actinic Keratosis

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Trial Information

A Randomized, Controlled Study to Evaluate the Photoallergic Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers Using an Open Application Photoallergic Test Design


Inclusion Criteria:



- are healthy males or females;

- in the case of females of childbearing potential, are using an acceptable form of
birth control and provide a negative urine pregnancy test;

- 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the photoallergic (sensitizing) potential of PEP005 Gel and it's vehicle on normal skin.

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Principal Investigator

Jonothan S Dosik, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

TKL Research, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

PEP005-024

NCT ID:

NCT00850681

Start Date:

February 2009

Completion Date:

April 2009

Related Keywords:

  • Actinic Keratosis
  • Peplin
  • PEP005
  • Keratosis
  • Keratosis, Actinic

Name

Location

TKL Research, Inc.Paramus, New Jersey  07652