Melanin and Dermal Uptake of Thirdhand Cigarette Smoke (NCT06020248) | Clinical Trial Compass
RecruitingNot Applicable
Melanin and Dermal Uptake of Thirdhand Cigarette Smoke
United States60 participantsStarted 2023-09-01
Plain-language summary
This is a pilot study of the effects of dermal melanin on dermal uptake and retention of nicotine. The initial hypothesis is that higher levels of dermal melanin will correlate with lower uptake and longer retention of nicotine in the skin and body.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult nonsmoker
* Aged 18-50
* Skin reflectance scores below 150 or above 249 using the Mexameter 18 instrument
* Healthy on the basis of medical history
* Systolic blood pressure \<150
* Diastolic blood pressure \<100
* C-reactive protein \<3.1 mg/ml
* Liver function (AST and ALT) in normal ranges
* kidney function (BUN) in normal ranges
* LDL\<131
* Blood glucose \<110
* Not exposed to tobacco SHS.
Exclusion Criteria:
* Dermal skin reflectance score between 150 and 249, as measured by the Mexameter 18 instrument.
* Positive SARS-CoV-2 antibody test
* Age 18 \< or \> 50
* Physician diagnosis of asthma, heart disease, hypertension, thyroid disease, diabetes, renal or liver impairment or glaucoma.
* Unstable psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder) or current use of more than two psychiatric medications
* Systolic blood pressure greater than or equal to 150
* Diastolic blood pressure greater than or equal to 100
* Blood glucose greater than or equal to 110
* LDL greater than or equal to130
* Pregnancy or breastfeeding (by urine hCG and/or history)
* Alcohol or illicit drug dependence within the past 5 years
* BMI \> 35 and \< 18
* Current illicit drug use (by history or urine test)
* More than 1 pack year smoking history
* Ever a daily marijuana smoker
* Smoked anything within the last 3 months
* Unable to hold allergy or other OTC medicines
* Occupational exposure to smoke, dusts OR fumes
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in blood concentrations of nicotine
Timeframe: Baseline and 3 hours
2
Total combined urinary concentrations of the nicotine metabolites cotinine and 3-hydroxycotinine