Analysis of Diphenylcyclopropenone (DPCP) in Normals

NCT ID: NCT01452594

Last Updated: 2013-09-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-09-30

Brief Summary

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.

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.

Conditions

Healthy Volunteers

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Diphenylcyclopropenone

topical gel administration to skin

Diphenylcyclopropenone

Intervention Type: DRUG

Topical administration

Placebo

Intervention Type: DRUG

Placebo

Interventions

Diphenylcyclopropenone

Topical administration

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rockefeller University

OTHER

Sponsor Role: lead

Responsible Party

Nicholas Gulati

Biomedical Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Krueger, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Rockefeller University

Locations

The Rockefeller University

New York, New York, United States

Countries

United States

Other Identifiers

JKR-0742

Identifier Type: -

Identifier Source: org_study_id