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Completed

NCT Number: NCT06932419

Ozone Reaction Products and Skin Health

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.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Environmental Health, School of Public Health, Fudan University

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ozone exposure

Other

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 exposure

Other

Participants' forearms were exposed to clean air for 2 h at a temperature and relative humidity of 27±2°C and 45%±5%, respectively.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Ozone Reaction Products and Their Acute Effects on Skin Health: a Randomized Controlled Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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