Study to Determine the Sensitizing Potential of PEP005 Topical Gel in Healthy Volunteers Using a Repeat Insult Patch Test Design

NCT00357916 | Completed Phase 1

• 1 other identifier: PEP005-005
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the sensitisation potential of PEP005 Topical Gel (0.01% concentration) on normal skin To evaluate skin irritation

Conditions

Healthy

Keywords

PEP005; Safety

Outcome Measures

Primary Outcomes (1)

• To determine the sensitization potential of PEP005 Topical Gel (0.01% concentration) on normal skin.

Secondary Outcomes (1)

• To evaluate skin irritation

Interventions

PEP005 Topical Gel (0.01% concentration) DRUG

Eligibility Criteria

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

You may qualify if:

• are healthy males or females (to be confirmed by medical history);
• are between 18 and 65 years of age;
• have Fitzpatick skin type I, II, III, or IV
• are willing to wait 6 hours after product application to shower;
• in the case of females of childbearing potential, are using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom with spermicide, diaphragm, or abstinence), have a negative urine pregnancy test at Screening, and submit to a pregnancy test prior to the challenge application;
• are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events;
• have acceptable vital signs (ie oral body temperature, blood pressure (systolic and diastolic), and pulse rate) taken and are willing to have them taken at the end of study (EOS, within 7 days of the initial challenge evaluation);
• complete a medical screening procedure; and
• read, understand and provide signed informed consent.

You may not qualify if:

• have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction;
• have Fitzpatrick skin type V or VI;
• have excessive hair on their back;
• current drug or alcohol abuse;
• have a clinically significant illness that may influence the outcome of the study within the 4 weeks prior to and during the study;
• are not willing to refrain from using topical/systemic analgesics such as aspirin, Aleve, Motrin, Advil, or Nuprin within 72 hours prior to and during the study (occasional use of Tylenol will be permitted);
• based on the investigator's initial examination should not participate in the study (ie, non compliance, inability to understand the study and give adequate informed consent)
• are using systemic/locally-acting medications which might counter or influence the study aim during the study and within 2 weeks prior to the beginning of the study (eg, antihistamines, or topical glucocorticosteroids);
• are using systemic/locally-acting anti-inflammitories which might counter or influence the study aim during the study and within 72 hours prior to the beginning of the study;
• are females who are pregnant, plan to become pregnant during the study, or are nursing a child;
• have a known sensitivity or allergy to constituents present in the material being evaluated; and/or
• have participated in any clinical testing of an investigational drug within 28-days or any clinical patch study within 14-days prior to or are currently participating in any clinical testing.

Sponsors & Collaborators

• Peplin: lead

Study Sites (1)

TKL Research Inc

Paramus, New Jersey, 07652, United States

Location

Related Publications (1)

• Dosik JS, Damstra M, Udell C, Welburn P. Evaluation of the skin sensitization, photoirritation, and photoallergic potential of ingenol mebutate gel in healthy volunteers. J Clin Aesthet Dermatol. 2014 Apr;7(4):35-42.

  PMID: 24765228 DERIVED

Study Officials

• Jonathon Dosik, MD

  TKL Research, Inc.

  PRINCIPAL INVESTIGATOR

• Peter Welburn, PhD

  Peplin Operations (Sponsor)

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 26, 2006
• First Posted: July 28, 2006
• Study Start: June 1, 2006
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: April 5, 2016

Record last verified: 2016-04

Locations

US (1)