HealthyTHS05NCT06020248
Melanin and Dermal Uptake of Thirdhand Cigarette Smoke
A study testing Wear clothing that has been exposed to cigarette smoke for 3 hours. in people with Healthy, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Wear clothing that has been exposed to cigarette smoke for 3 hours.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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
- Concurrent participation in another clinical trial
- Unable to communicate in English
- No social security number
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
Abel Huang, Abel.Huang@ucsf.edu
Suzyann Schick, PhD
About this study
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.
Read the detailed description
This is an interventional pharmacokinetic study comparing the uptake and metabolism of nicotine from smoke-exposed clothing in people with low high levels of dermal melanin and people with high levels of dermal melanin. The study will measure nicotine and metabolites of nicotine in the blood during exposure and in urine for 10 days after exposure.
- Conditions
- Healthy
- Being tested
- Wear clothing that has been exposed to cigarette smoke for 3 hours.
- Keywords
- Thirdhand tobacco smoke, Dermal, Exposure, Tobacco Smoke Pollution, Melanin, Nicotine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wear clothing that has been exposed to cigarette smoke for 3 hours.Other
Cotton clothing is exposed to smoke from Marlboro Red (hard pack) cigarettes at 1-1.2 mg/m3 repeatedly, until total exposure equals 3 grams total particulate material. When tested after exposure, the clothing typically contained 59.15 +/- 18 µg nicotine and 42 +/- 24 ng NNK per gram. The mass of the clothing varies by size, but the average combination of pants and shirt contains 32 mgs nicotine and 23 µg NNK.
| Study group | Role | What they receive |
|---|---|---|
| Low melanin | Experimental | Individuals with skin reflectance scores below 150 using the Mexameter 18 instrument. Receives: Other: Wear clothing that has been exposed to cigarette smoke for 3 hours. |
| High melanin | Experimental | Individuals with skin reflectance scores above 249 using the Mexameter 18 instrument Receives: Other: Wear clothing that has been exposed to cigarette smoke for 3 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood concentrations of nicotine
The study will measure concentration of nicotine in the blood before and after the dermal exposure to nicotine.
Measured: Baseline and 3 hours
Total combined urinary concentrations of the nicotine metabolites cotinine and 3-hydroxycotinine
The study will measure urinary metabolites of nicotine in the first void of the day for 10 days after exposure and sum the total mass of metabolites.
Measured: First void, collected for 10 days
Secondary outcomes (1)
Urinary concentration of the NNK metabolite NNAL
The study will measure urinary metabolites of NNK in the first void of the day for 10 days after exposure and sum the total mass of metabolites.
Measured: First void, collected for 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Sep 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Dermal uptake, metabolism and excretion of nicotine in participants with high and low levels of dermal melanin will be compared.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzaynn F Schick, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020248
- Sponsor's protocol ID
- 22-37861
- Acronym
- THS05
- Status last verified
- Jun 2026
- First submitted
- 25 Aug 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melanin and Dermal Uptake of Thirdhand Cigarette Smoke
- ClinicalTrials.gov ID
- NCT06020248
- Acronym / sponsor ID
- THS05 / 22-37861
- Conditions
- Healthy
- Keywords
- Thirdhand tobacco smoke, Dermal, Exposure, Tobacco Smoke Pollution, Melanin, Nicotine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 31 Aug 2023 (actual)
- 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.
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.
Detailed description
This is an interventional pharmacokinetic study comparing the uptake and metabolism of nicotine from smoke-exposed clothing in people with low high levels of dermal melanin and people with high levels of dermal melanin. The study will measure nicotine and metabolites of nicotine in the blood during exposure and in urine for 10 days after exposure.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dermal uptake, metabolism and excretion of nicotine in participants with high and low levels of dermal melanin will be compared.
| Arm | Type | Receives |
|---|---|---|
| Low melanin | Experimental | Other: Wear clothing that has been exposed to cigarette smoke for 3 hours.Individuals with skin reflectance scores below 150 using the Mexameter 18 instrument. |
| High melanin | Experimental | Other: Wear clothing that has been exposed to cigarette smoke for 3 hours.Individuals with skin reflectance scores above 249 using the Mexameter 18 instrument |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (21 listed)
- 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
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 |
|---|---|---|
| Wear clothing that has been exposed to cigarette smoke for 3 hours.Cotton clothing is exposed to smoke from Marlboro Red (hard pack) cigarettes at 1-1.2 mg/m3 repeatedly, until total exposure equals 3 grams total particulate material. When tested after exposure, the clothing typically contained 59.15 +/- 18 µg nicotine and 42 +/- 24 ng NNK per gram. The mass of the clothing varies by size, but the average combination of pants and shirt contains 32 mgs nicotine and 23 µg NNK. | Other | High melanin, Low melanin |
Primary outcome
Change in blood concentrations of nicotine
Time frame: Baseline and 3 hours
The study will measure concentration of nicotine in the blood before and after the dermal exposure to nicotine.
Total combined urinary concentrations of the nicotine metabolites cotinine and 3-hydroxycotinine
Time frame: First void, collected for 10 days
The study will measure urinary metabolites of nicotine in the first void of the day for 10 days after exposure and sum the total mass of metabolites.
1 secondary outcome
Urinary concentration of the NNK metabolite NNAL
Time frame: First void, collected for 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Suzaynn F Schick, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wear clothing that has been exposed to cigarette smoke for 3 hours. in people with Healthy, run by University of California, San Francisco 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 12 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suzaynn F Schick, PhD (415-514-3535, suzaynn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood concentrations of nicotine (time frame: Baseline and 3 hours). The study lists 2 primary outcomes in all. 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 16 Jun 2026.