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

This study has been completed.
Sponsor:
Information provided by:
Peplin
ClinicalTrials.gov Identifier:
NCT00357916
First received: July 26, 2006
Last updated: December 22, 2008
Last verified: December 2008
  Purpose

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

To evaluate skin irritation


Condition Intervention Phase
Healthy
Drug: PEP005 Topical Gel (0.01% concentration)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Randomized, Controlled Study to Evaluate the Sensitizing Potential of PEP005 Topical Gel (0.01% Concentration) in Healthy Volunteers Using a Repeat Insult Patch Test Design

Resource links provided by NLM:


Further study details as provided by Peplin:

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

Secondary Outcome Measures:
  • To evaluate skin irritation

Estimated Enrollment: 200
Study Start Date: June 2006
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Detailed Description:

This is a repeat insult patch test study. On treatment days, the investigational product PEP005 Topical Gel (0.01% concentration) and vehicle control will be applied under open conditions to sites on the infrascapular region of the back 3 times weekly for 3 weeks (9 applications in total) during the induction phase. Following a rest period of approximatley 10-14 days, a single challenge application will be performed. Local tolerability will be assessed visually using an ordinal scoring system. If a cutaneous response observed in the challenge phase indicates possible sensitisation, or at the discretion of the investigator, a rechallenge will occur

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. are healthy males or females (to be confirmed by medical history);
  2. are between 18 and 65 years of age;
  3. have Fitzpatick skin type I, II, III, or IV
  4. are willing to wait 6 hours after product application to shower;
  5. 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;
  6. 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;
  7. 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);
  8. complete a medical screening procedure; and
  9. read, understand and provide signed informed consent.

Exclusion Criteria:

  1. 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;
  2. have Fitzpatrick skin type V or VI;
  3. have excessive hair on their back;
  4. current drug or alcohol abuse;
  5. have a clinically significant illness that may influence the outcome of the study within the 4 weeks prior to and during the study;
  6. 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);
  7. 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)
  8. 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);
  9. 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;
  10. are females who are pregnant, plan to become pregnant during the study, or are nursing a child;
  11. have a known sensitivity or allergy to constituents present in the material being evaluated; and/or
  12. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357916

Locations
United States, New Jersey
TKL Research Inc
Paramus, New Jersey, United States, 07652
Sponsors and Collaborators
Peplin
Investigators
Principal Investigator: Jonathon Dosik, MD TKL Research, Inc.
Study Director: Peter Welburn, PhD Peplin Operations (Sponsor)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00357916     History of Changes
Other Study ID Numbers: PEP005-005
Study First Received: July 26, 2006
Last Updated: December 22, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Peplin:
PEP005
Safety

ClinicalTrials.gov processed this record on September 18, 2014