Ozone Reaction Products and Skin Health

February 28, 2026 updated by: Haidong Kan, Fudan University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Department of Environmental Health, School of Public Health, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Living in Shanghai during the study period;
  • Having healthy skin conditions on both forearms.

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exposure group
The forearm assigned to this group will be exposed to 200 ppb ozone for 2 hours.
Other: Ozone exposure
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.
Sham Comparator: Control group
The forearm assigned to this group will be exposed to clean air for 2 hours.
Other: Clean air exposure
Participants' forearms were exposed to clean air for 2 h at a temperature and relative humidity of 27±2°C and 45%±5%, respectively.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Immediately before exposure and immediately after exposure.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in skin hydration
Time Frame: Immediately before exposure, immediately after exposure, and 24 hours after exposure.
Changes in the amount of skin hydration, which will be measured by a hydration meter.
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 transepidermal water loss on the forearm, which will be measured by an evaporimeter.
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.
Changes in the pH level of skin, which will be measured by a PH meter.
Immediately before exposure, immediately after exposure, and 24 hours after exposure.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Differences in skin microbiome
Time Frame: Immediately after exposure.
Differences in skin microbiome between ozone exposure and clean air exposure, which will be measured using sterile swab samples.
Immediately after exposure.
Changes in IL-1α
Time Frame: Immediately before exposure and immediately after exposure.
Changes in the level of interleukin-1α on the forearms, which will be measured using D-squame tape samples.
Immediately before exposure and immediately after exposure.
Changes in pyrrolidone carboxylic acid
Time Frame: Immediately before exposure, and immediately after exposure.
Changes in the amount of pyrrolidone carboxylic acid on the forearms, which will be measured using D-squame tape samples.
Immediately before exposure, and immediately after exposure.
Changes in total protein levels of stratum corneum
Time Frame: Immediately before exposure, and immediately after exposure.
Changes in the amount of total protein on forearms stratum corneum, which will be detected using D-squame tapes.
Immediately before exposure, and immediately after exposure.
Changes in carbonyl protein
Time Frame: Immediately before exposure, and immediately after exposure.
Changes in the amount of carbonyl protein on the forearms, which will be measured using D-squame tape samples.
Immediately before exposure, and immediately after exposure.
Changes in total antioxidant capacity
Time Frame: Immediately before exposure, and immediately after exposure.
Changes in the amount of total antioxidant capacity on the forearms, which will be measured using D-squame tape samples.
Immediately before exposure, and immediately after exposure.
Changes in IL-1RA
Time Frame: Immediately before exposure, and immediately after exposure.
Changes in the level of Interleukin-1 receptor antagonist on the forearms, which will be measured using D-squame tape samples.
Immediately before exposure, and immediately after exposure.
Changes in KLK5
Time Frame: Immediately before exposure and immediately after exposure.
Changes in the expression level of Kallikrein related peptidase 5, which will be measured using D-squame tape samples.
Immediately before exposure and immediately after exposure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fudan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yue Niu, PhD, Department of Environmental Health, School of Public Health, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 28, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FDUEH-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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