Clinical trial · Interventional
Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers
A Phase I Study of Topical Myristyl Nicotinate Cream on Human Skin in Healthy Volunteers
NCT00619060CI-TRIAL-00021287completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Topical Myristyl Nicotinate Cream | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Myristyl (right), Placebo (Left)
- description
- 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
- interventionNames
- Drug: Topical Myristyl Nicotinate Cream
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Myristyl (Left), Placebo (Right)
- description
- 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
- interventionNames
- Drug: Topical Myristyl Nicotinate Cream
- Drug: Placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.