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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00850681

Enrollment

Registered

2009-02-25

Start date

2009-02-28

Completion date

2009-04-30

Last updated

2015-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis

Keywords

Peplin, PEP005

Brief summary

This Phase 1 study is designed to determine the photoallergic potential of PEP005 Gel, 0.01% and it's vehicle on normal skin.

Interventions

DRUGPEP005 (ingenol mebutate) Gel

PEP005 (ingenol mebutate) Gel, 0.01%

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
To determine the photoallergic (sensitizing) potential of PEP005 Gel and it's vehicle on normal skin.	6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026