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

NCT01302925 | Completed Phase 1

• 1 other identifier: LP0041-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy; Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• Local Skin Responses

  Up to 8 days

Study Arms (2)

PEP005 Gel 0.05%/2 days

EXPERIMENTAL

Subjects will be exposed to investigational product for 2 consecutive days.

Drug: PEP005 Gel

PEP005 Gel 0.015%/3 days

EXPERIMENTAL

Subjects will be exposed to investigational product for 3 consecutive days.

Drug: PEP005 Gel

Interventions

PEP005 Gel DRUG

PEP005 Gel 0.05% for 2 consecutive days

PEP005 Gel 0.05%/2 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peplin: lead
• LEO Pharma: collaborator

Study Sites (1)

TKL Research

Paramus, New Jersey, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jonathan Dosik, MD

  TKL Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 22, 2011
• First Posted: February 24, 2011
• Study Start: February 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: September 14, 2015

Record last verified: 2012-05

Locations

US (1)