Healthy VolunteersNCT01452594
Analysis of Diphenylcyclopropenone (DPCP) in Normals
An observational study of Healthy Volunteers, run by Rockefeller University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Diphenylcyclopropenone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy Volunteers
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rockefeller University
New York, New York, 10065
About this study
Official title: Analysis of Immune Reactions Occurring in Normal Volunteers Upon Administration of the Topical Immunomodulator Diphenylcyclopropenone
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.
Read the 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
- Being tested
- Diphenylcyclopropenone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiphenylcyclopropenoneDrug
Topical administration
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Diphenylcyclopropenone | topical gel administration to skin Receives: Drug: Diphenylcyclopropenone; Drug: Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Gulati, Rockefeller University
- Investigators
- James Krueger, MD,PhD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452594
- Sponsor's protocol ID
- JKR-0742
- Status last verified
- Sep 2013
- First submitted
- 12 Oct 2011
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Immune Reactions Occurring in Normal Volunteers Upon Administration of the Topical Immunomodulator Diphenylcyclopropenone
- ClinicalTrials.gov ID
- NCT01452594
- Acronym / sponsor ID
- JKR-0742
- Conditions
- Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 17 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diphenylcyclopropenone | – | Drug: Diphenylcyclopropenone, Drug: Placebotopical gel administration to skin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Volunteers
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiphenylcyclopropenoneTopical administration | Drug | Diphenylcyclopropenone |
| PlaceboPlacebo | Drug | Diphenylcyclopropenone |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Krueger, MD,PhD principal investigator
Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Rockefeller University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2013.