PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate Gel Followed by Hand Washing in Healthy Subjects

Healthy Clinical Trial

Official title:

PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate 0.05% and 0.015% Gel Followed by Hand Washing in Healthy Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01302925
• Other study ID #: LP0041-01
• Status: Completed
• Phase: Phase 1
• First received: February 22, 2011
• Last updated: September 11, 2015
• Start date: February 2011
• Est. completion date: March 2011

Study information

• Verified date: May 2012
• Source: Peplin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this phase 1 trial is to investigate the local tolerability on the finger following exposure to PEP005 Gel 0.015% or 0.05% and hand washing once daily, for 2 or 3 consecutive days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be male or female and at least 18 years of age

• Female patients must be of: non-childbearing potential or if of childbearing potential then have a negative serum and urine pregnancy test and using effective contraception

• Ability to provide informed consent

Exclusion Criteria:

• Have received treatment with immunomodulators, or interferon/interferon inducers or systematic medications that suppress the immune system in the last 4 weeks

• Exposed to prescribed systemic (take as tablet, injection etc) or topical (gel, cream, lotion) medication within the last 7 days

• Have any signs of skin irritation or damaged skin at or around the dominant index finger

• Have worked in an occupation with a high risk of being in contact with irritative material (eg. chemicals, painting) on their hands, especially fingers

• Those who are currently participating in any other clinical trial

• Those known or suspected of not being able to comply with the requirements of the protocol

• Females who are pregnant or are breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Actinic Keratosis
• Healthy
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• PEP005 Gel
PEP005 Gel 0.05% for 2 consecutive days
• PEP005 Gel
PEP005 Gel 0.015% for 3 consecutive days

Locations

Country	Name	City	State
United States	TKL Research	Paramus	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Peplin	LEO Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Skin Responses		Up to 8 days	Yes

External Links

•   Clinical Trials at LEO Pharma
•   FDA