Skin HealthNCT06932419
Ozone Reaction Products and Skin Health
A study testing Ozone exposure and Clean air exposure in people with Skin Health, run by Fudan University at 1 site in China.
Trial summary
This is a randomized controlled human exposure study. Investigators aim to investigate the products of ozone-sebum reactions and their acute effects on skin health of healthy young adults. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Health
- What is being tested?
- Ozone exposure and Clean air exposure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2025to 28 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Living in Shanghai during the study period;
- Having healthy skin conditions on both forearms.
Who cannot join
- Subjects with a history of smoking and alcohol abuse;
- Subjects with a regular use of medication and dietary supplements within 2 months prior to enrollment;
- Subjects with severe skin diseases, such as atopic dermatitis, eczema, or severe acne;
- Subjects with allergic diseases, such as allergic rhinitis, allergic asthma, or atopy, or history of allergic reactions within 2 months prior to enrollment;
- Subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, or hypertension;
- Subjects with respiratory diseases, such as asthma, acute or chronic bronchitis, or pneumonia;
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- Subjects with chronic diseases, such as diabetes, chronic hepatitis, or kidney disease;
- Subjects with cutaneous abnormalities on forearm, such as severe pigmentation, multiple nevus, or tattooing;
- Subjects who underwent cosmetic intervention on forearms within 2 months prior to enrollment, such as whitening treatments, UV exposure therapies, depigmentation procedures, or tanning;
- Females in pregnancy or lactation status.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Environmental Health, School of Public Health, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Ozone Reaction Products and Their Acute Effects on Skin Health: a Randomized Controlled Study
This is a randomized controlled human exposure study. Investigators aim to investigate the products of ozone-sebum reactions and their acute effects on skin health of healthy young adults.
Read the detailed description
The investigators will conduct a randomized, controlled human exposure study involving 40 healthy young adults in Shanghai, China. Each participant will have both forearms simultaneously exposed-one in a clean air chamber and the other in an ozone chamber-for 2 hours. The ozone concentration at the ozone chamber inlet will be maintained at 200 ppb. The temperature and relative humidity in both chambers will be maintained at 27±2℃ and 45%±5%, respectively. Health examinations will be conducted at three time points: immediately before exposure, immediately after exposure, and 24 hours after exposure. These examinations will include skin measurements and sampling.
- Conditions
- Skin Health
- Being tested
- Ozone exposure, Clean air exposure
- Keywords
- Ozone reaction products, Skin health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozone exposureOther
Participants' forearms were exposed to 200 ppb ozone for 2 h at a temperature and relative humidity of 27±2°C and 45%±5%, respectively.
Clean air exposureOther
Participants' forearms were exposed to clean air for 2 h at a temperature and relative humidity of 27±2°C and 45%±5%, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Exposure group | Experimental | The forearm assigned to this group will be exposed to 200 ppb ozone for 2 hours. Receives: Other: Ozone exposure |
| Control group | Sham comparator | The forearm assigned to this group will be exposed to clean air for 2 hours. Receives: Other: Clean air exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in chemical exposome level on the forearm skin
Changes in the amount and level of chemical contaminants between ozone and clean air exposures, which will be detected using non-targeted or targeted methods.
Measured: Immediately before exposure and immediately after exposure.
Secondary outcomes (3)
Changes in skin hydration
Changes in the amount of skin hydration, which will be measured by a hydration meter.
Measured: Immediately before exposure, immediately after exposure, and 24 hours after exposure.
Changes in TEWL
Changes in transepidermal water loss on the forearm, which will be measured by an evaporimeter.
Measured: Immediately before exposure, immediately after exposure, and 24 hours after exposure.
Changes in pH
Changes in the pH level of skin, which will be measured by a PH meter.
Measured: Immediately before exposure, immediately after exposure, and 24 hours after exposure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start28 Apr 2025
- Primary completion28 Jan 2026
- Study completion28 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin HealthStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haidong Kan, Fudan University
- Investigators
- Yue Niu, PhD, Study director, Department of Environmental Health, School of Public Health, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932419
- Sponsor's protocol ID
- FDUEH-10
- Status last verified
- Feb 2026
- First submitted
- 10 Apr 2025
- Last updated
- 3 Mar 2026
- Results posted
- 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 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ozone Reaction Products and Their Acute Effects on Skin Health: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06932419
- Acronym / sponsor ID
- FDUEH-10
- Conditions
- Skin Health
- Keywords
- Ozone reaction products, Skin health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 17 Apr 2025 (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 randomized controlled human exposure study. Investigators aim to investigate the products of ozone-sebum reactions and their acute effects on skin health of healthy young adults.
Detailed description
The investigators will conduct a randomized, controlled human exposure study involving 40 healthy young adults in Shanghai, China. Each participant will have both forearms simultaneously exposed-one in a clean air chamber and the other in an ozone chamber-for 2 hours. The ozone concentration at the ozone chamber inlet will be maintained at 200 ppb. The temperature and relative humidity in both chambers will be maintained at 27±2℃ and 45%±5%, respectively. Health examinations will be conducted at three time points: immediately before exposure, immediately after exposure, and 24 hours after exposure. These examinations will include skin measurements and sampling.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure group | Experimental | Other: Ozone exposureThe forearm assigned to this group will be exposed to 200 ppb ozone for 2 hours. |
| Control group | Sham comparator | Other: Clean air exposureThe forearm assigned to this group will be exposed to clean air for 2 hours. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Living in Shanghai during the study period;
- Having healthy skin conditions on both forearms.
Key exclusion criteria (10 listed)
- Subjects with a history of smoking and alcohol abuse;
- Subjects with a regular use of medication and dietary supplements within 2 months prior to enrollment;
- Subjects with severe skin diseases, such as atopic dermatitis, eczema, or severe acne;
- Subjects with allergic diseases, such as allergic rhinitis, allergic asthma, or atopy, or history of allergic reactions within 2 months prior to enrollment;
- Subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, or hypertension;
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 |
|---|---|---|
| Ozone exposureParticipants' forearms were exposed to 200 ppb ozone for 2 h at a temperature and relative humidity of 27±2°C and 45%±5%, respectively. | Other | Exposure group |
| Clean air exposureParticipants' forearms were exposed to clean air for 2 h at a temperature and relative humidity of 27±2°C and 45%±5%, respectively. | Other | Control group |
Primary outcome
Changes in chemical exposome level on the forearm skin
Time frame: Immediately before exposure and immediately after exposure.
Changes in the amount and level of chemical contaminants between ozone and clean air exposures, which will be detected using non-targeted or targeted methods.
3 secondary outcomes
Changes in skin hydration
Time frame: Immediately before exposure, immediately after exposure, and 24 hours after exposure.
Changes in TEWL
Time frame: Immediately before exposure, immediately after exposure, and 24 hours after exposure.
Changes in pH
Time frame: Immediately before exposure, immediately after exposure, and 24 hours after exposure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Yue Niu, PhD study director
Department of Environmental Health, School of Public Health, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozone exposure and Clean air exposure in people with Skin Health, run by Fudan University at 1 site in China.
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 2 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 3 Mar 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 China. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in chemical exposome level on the forearm skin (time frame: Immediately before exposure and immediately after exposure.). 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 3 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.