Ozone Reaction Products and Skin Health

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: Completed
• Conditions: Skin Health
• Intervention / Treatment: Other: Ozone exposure; Other: Clean air exposure

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: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Immediately before exposure and immediately after exposure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in skin hydration	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	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	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

Outcome Measure	Measure Description	Time Frame
Differences in skin microbiome	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	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	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	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	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	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	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	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

• Sponsor: Fudan University
• Investigators: Study Director: Yue Niu, PhD, Department of Environmental Health, School of Public Health, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2025
• Primary Completion (Actual): January 28, 2026
• Study Completion (Actual): January 28, 2026

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Skin health; Ozone reaction products
• Other Study ID 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