Ozone Reaction Products and Skin Health

Not Applicable

Not yet recruiting

• Conditions: Skin Health

• Registration Number: NCT06932419
• Lead Sponsor: Fudan University

Brief 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.

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 Timeline

• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study First Posted: 2025-04-17
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-08
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in chemical exposome level on the forearm skin	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 Outcome Measures

Name	Time	Method
Changes in skin hydration	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.
Changes in TEWL	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.
Changes in pH	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.

Trial Locations

Locations (1)

Department of Environmental Health, School of Public Health, Fudan University; 🇨🇳 Shanghai, Shanghai, China