HealthyPhase 1NCT00619060
Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers
A Phase 1 study testing Topical Myristyl Nicotinate Cream in people with Healthy, run by University of Arizona at 1 site in United States.
Trial summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of topical myristyl nicotinate cream may stop skin cancer from forming. PURPOSE: This randomized phase I trial is studying the side effects and best way to give topical myristyl nicotinate cream on the skin of healthy… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Topical Myristyl Nicotinate Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jul 2008
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects 18 years of age or older with normal skin
- Have used no topical medications on the skin of the upper extremities, except for emollients or sunscreens, for at least 30 days prior to study entry
- Agree to limit sun exposure as much as possible and wear protective clothing on the forearms in place of using sunscreens or moisturizers
- Ability to understand and willingness to sign an informed consent before initiation of therapy after the nature of the study has been explained to them
- Females must be surgically sterile by hysterectomy or post menopausal
Who cannot join
- Subjects with no signs of inflammation or irritation of the skin on the forearms
- Subjects with prior history of actinic keratosis or skin cancer on the forearm
- Females of child bearing potential
- Subjects with any concurrent therapy (e.g., retinoids, fluorouracil) on the forearms that may interfere with clinical evaluations
- Subjects taking oral supplemental niacin, by itself or in the form of a multi-vitamin that exceeds 40 mg/day
- No known immunosuppression by virtue of medication or disease, including AIDS patients, subjects taking oral prednisone, and subjects on immunosuppressants/immunomodulators( cyclosporine, chemotherapeutic agents, or biologic therapy), determined by the examining investigator/co-investigator
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- Uncontrolled intercurrent illness including, but not limited to any of ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Subjects who have had invasive cancer within the past 5 years
- Skin conditions felt by the study physician to contraindicate enrollment including, but not limited to, psoriasis or atopic dermatitis within a proposed treatment area
- Less than 30 days since prior and no concurrent or planned participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724-5024
About this study
Official title: A Phase I Study of Topical Myristyl Nicotinate Cream on Human Skin in Healthy Volunteers
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of topical myristyl nicotinate cream may stop skin cancer from forming.
PURPOSE: This randomized phase I trial is studying the side effects and best way to give topical myristyl nicotinate cream on the skin of healthy volunteers.
Read the detailed description
OBJECTIVES:
- To determine if topical myristyl nicotinate (MN) is a safe, tolerable treatment in healthy volunteers.
- To determine if topically administered MN cream is associated with any significant local or systemic toxicity in normal human subjects in a one-month period.
OUTLINE: Participants are randomized to 1 of 2 treatment arms and serve as their own controls.
- Arm I: Participants apply topical myristyl nicotinate to one forearm and topical placebo to the other forearm once daily for 4 weeks.
- Arm II: Participants receive treatment as in arm I but on opposite forearms. All participants undergo blood collection for chemistry analysis (SMA-20 and CBC) at baseline and at 2 and 4 weeks.
- Conditions
- Healthy
- Being tested
- Topical Myristyl Nicotinate Cream, Placebo
- Keywords
- skin cancer, healthy, no evidence of disease
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Myristyl Nicotinate CreamDrug
Also called Myristyl, Nicotinate, Cream
Participants apply topical myristyl nicotinate to one forearm once daily for 4 weeks.
PlaceboDrug
Participants apply topical placebo to one forearm once daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Myristyl (right), Placebo (Left) | Experimental | Participants apply topical myristyl nicotinate to the right forearm and topical placebo to the left forearm once daily for 4 weeks; Myristyl (Right), Placebo (Left) Topical Myristyl Nicotinate Cream and Placebo Receives: Drug: Topical Myristyl Nicotinate Cream; Drug: Placebo |
| Myristyl (Left), Placebo (Right) | Experimental | Participants apply topical myristyl nicotinate to the left forearm and topical placebo to the right forearm once daily for 4 weeks; Myristyl (Left), Placebo (Right)Topical Myristyl Nicotinate Cream and Placebo Receives: Drug: Topical Myristyl Nicotinate Cream; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Adverse Events by Treatment.
Comparison of number of participants with adverse events by treatment.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startAug 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Clara Curiel, MD, Study chair, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619060
- Sponsor's protocol ID
- CDR0000582627
- Other IDs
- P30CA023074, UARIZ-BIO-07-085
- Status last verified
- Sep 2014
- First submitted
- 19 Feb 2008
- Last updated
- 10 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Topical Myristyl Nicotinate Cream on Human Skin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00619060
- Acronym / sponsor ID
- CDR0000582627
- Conditions
- Healthy
- Keywords
- skin cancer, healthy, no evidence of disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Posted 10 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of topical myristyl nicotinate cream may stop skin cancer from forming.
PURPOSE: This randomized phase I trial is studying the side effects and best way to give topical myristyl nicotinate cream on the skin of healthy volunteers.
Detailed description
OBJECTIVES:
- To determine if topical myristyl nicotinate (MN) is a safe, tolerable treatment in healthy volunteers.
- To determine if topically administered MN cream is associated with any significant local or systemic toxicity in normal human subjects in a one-month period.
OUTLINE: Participants are randomized to 1 of 2 treatment arms and serve as their own controls.
- Arm I: Participants apply topical myristyl nicotinate to one forearm and topical placebo to the other forearm once daily for 4 weeks.
- Arm II: Participants receive treatment as in arm I but on opposite forearms. All participants undergo blood collection for chemistry analysis (SMA-20 and CBC) at baseline and at 2 and 4 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myristyl (right), Placebo (Left) | Experimental | Drug: Topical Myristyl Nicotinate Cream, Drug: PlaceboParticipants apply topical myristyl nicotinate to the right forearm and topical placebo to the left forearm once daily for 4 weeks; Myristyl (Right), Placebo (Left) Topical Myristyl Nicotinate Cream and Placebo |
| Myristyl (Left), Placebo (Right) | Experimental | Drug: Topical Myristyl Nicotinate Cream, Drug: PlaceboParticipants apply topical myristyl nicotinate to the left forearm and topical placebo to the right forearm once daily for 4 weeks; Myristyl (Left), Placebo (Right)Topical Myristyl Nicotinate Cream and Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects 18 years of age or older with normal skin
- Have used no topical medications on the skin of the upper extremities, except for emollients or sunscreens, for at least 30 days prior to study entry
- Agree to limit sun exposure as much as possible and wear protective clothing on the forearms in place of using sunscreens or moisturizers
- Ability to understand and willingness to sign an informed consent before initiation of therapy after the nature of the study has been explained to them
- Females must be surgically sterile by hysterectomy or post menopausal
Key exclusion criteria (10 listed)
- Subjects with no signs of inflammation or irritation of the skin on the forearms
- Subjects with prior history of actinic keratosis or skin cancer on the forearm
- Females of child bearing potential
- Subjects with any concurrent therapy (e.g., retinoids, fluorouracil) on the forearms that may interfere with clinical evaluations
- Subjects taking oral supplemental niacin, by itself or in the form of a multi-vitamin that exceeds 40 mg/day
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 |
|---|---|---|
| Topical Myristyl Nicotinate CreamAlso: Myristyl, Nicotinate, CreamParticipants apply topical myristyl nicotinate to one forearm once daily for 4 weeks. | Drug | Myristyl (Left), Placebo (Right), Myristyl (right), Placebo (Left) |
| PlaceboParticipants apply topical placebo to one forearm once daily for 4 weeks. | Drug | Myristyl (Left), Placebo (Right), Myristyl (right), Placebo (Left) |
Primary outcome
Participants With Adverse Events by Treatment.
Time frame: 30 Days
Comparison of number of participants with adverse events by treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clara Curiel, MD study chair
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Topical Myristyl Nicotinate Cream in people with Healthy, run by University of Arizona 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 5 inclusion and 10 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 10 Mar 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Participants With Adverse Events by Treatment. (time frame: 30 Days). It is what the study was designed to measure, not a finding.
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 10 Mar 2016.