Analysis of Diphenylcyclopropenone (DPCP) in Normals

NCT01452594 | Completed

• 1 other identifier: JKR-0742
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Study Arms (1)

Diphenylcyclopropenone

topical gel administration to skin

Drug: Diphenylcyclopropenone; Drug: Placebo

Interventions

Diphenylcyclopropenone DRUG

Topical administration

Diphenylcyclopropenone

Placebo DRUG

Placebo

Diphenylcyclopropenone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy Volunteers

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Skin Biopsy

MeSH Terms

Interventions

diphenylcyclopropenone

Study Officials

• James Krueger, MD,PhD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Biomedical Fellow

Study Record Dates

• First Submitted: October 12, 2011
• First Posted: October 17, 2011
• Study Start: October 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

US (1)