Analysis of Diphenylcyclopropenone (DPCP) in Normals

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nicholas Gulati, Rockefeller University
ClinicalTrials.gov Identifier:
NCT01452594
First received: October 12, 2011
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

The drug diphenylcyclopropenone, or DPCP, modifies the immune system and has been shown to be effective in treating certain kinds of cancer. This study hopes to improve our understanding of how this drug helps create an effective immune response.


Condition Intervention
Healthy Volunteers
Drug: Diphenylcyclopropenone
Drug: Placebo

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Immune Reactions Occurring in Normal Volunteers Upon Administration of the Topical Immunomodulator Diphenylcyclopropenone

Further study details as provided by Rockefeller University:

Biospecimen Retention:   Samples With DNA

Skin Biopsy


Estimated Enrollment: 30
Study Start Date: October 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Diphenylcyclopropenone
topical gel administration to skin
Drug: Diphenylcyclopropenone
Topical administration
Drug: Placebo
Placebo

Detailed Description:

The immune system is the primary line of defense against infections and other things perceived as foreign to the body. Unfortunately, this immune system often fails to eliminate tumors or other cancerous growths. The drug diphenylcyclopropenone, or DPCP, modifies the immune system and has been shown to be effective in treating certain kinds of cancer. This study hopes to improve our understanding of how this drug helps create an effective immune response. In order to reach this goal, normal volunteers will be given the DPCP drug in the form of a gel or a placebo gel (gel without the active chemical) on a few small areas of skin. Then, biopsies will be taken of the skin at the sites where the active drug was placed. Also, small biopsies will be taken from opposite areas of skin which received placebo gel to serve as controls. The biopsied skin samples will then be studied by methods such as immunohistochemistry and microarray analysis which will help define the immune reaction caused by DPCP. The rationale for the study is to better understand how the immune system can be activated to produce cells that may fight infections or cancers.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy Volunteers

Criteria

Inclusion Criteria:

  • Male or non-pregnant female between 18 and 60 years of age
  • Able to give verbal and written informed consent
  • For women of childbearing potential (WOCBP) or in men whose partners may become pregnant, willingness to use an acceptable method of contraception to prevent pregnancy for the duration of the study (while receiving study medication and for one month following the last dose of study medication). Acceptable forms of contraception are listed in the protocol.
  • Must have a negative urine pregnancy test (for WOCBP)

Exclusion Criteria:

  • Subjects taking any of the following systemic or topical therapies within 4 weeks of enrollment: corticosteroids, immunosuppressants, and/or any other medications that may affect the outcome of the study
  • Known sensitivity to bandage or adhesive tape.
  • Subjects who have active localized or systemic medical conditions that, in the opinion of the investigator, would preclude or make unsafe their participation in the study
  • Subjects with any underlying concomitant diagnosis that may influence immune reactions (e.g. eczema, psoriasis, lupus)
  • Subjects who are nursing mothers, pregnant, or planning to become pregnant at anytime during the course of the study or within 30 days of study completion
  • Subjects who are unable to comply with study procedures, communicate effectively, cooperate with the investigator, or are unable to understand the study
  • Subjects who have been treated with another investigational device or drug within 30 days of enrollment
  • HIV positive as determined by self-reported history and/or a HIV POCT at screening
  • History, physical, social or lab findings suggestive of any medical or psychological condition that would, in the opinion of the PI, make the candidate ineligible for the study
  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: NCT01452594

Locations
United States, New York
The Rockefeller University
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Investigators
Principal Investigator: James Krueger, MD,PhD Rockefeller University
  More Information

No publications provided

Responsible Party: Nicholas Gulati, Biomedical Fellow, Rockefeller University
ClinicalTrials.gov Identifier: NCT01452594     History of Changes
Other Study ID Numbers: JKR-0742
Study First Received: October 12, 2011
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 29, 2014