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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00850681
Other study ID # PEP005-024
Secondary ID
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 photoallergic potential of PEP005 Gel, 0.01% and it's vehicle on normal skin.


Recruitment information / eligibility

Status Completed
Enrollment 50
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:

- 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.

Study Design

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


Related Conditions & MeSH terms


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 photoallergic (sensitizing) potential of PEP005 Gel and it's vehicle on normal skin. 6 weeks Yes
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