Melanin and Dermal Uptake of Thirdhand Cigarette Smoke (NCT06020248) | Clinical Trial Compass
UnknownNot Applicable
Melanin and Dermal Uptake of Thirdhand Cigarette Smoke
United States60 participantsStarted 2023-09
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 range18 Years – 50 Years
SexALL
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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
*…
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