Ozone Reaction Products and Skin Health

NCT ID: NCT06932419

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2026-12-31

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.

Conditions

Skin Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Exposure group

The forearm assigned to this group will be exposed to 200 ppb ozone for 2 hours.

Group Type: EXPERIMENTAL

Ozone exposure

Intervention Type: 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.

Control group

The forearm assigned to this group will be exposed to clean air for 2 hours.

Group Type: SHAM_COMPARATOR

Clean air exposure

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Haidong Kan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yue Niu, PhD

Role: STUDY_DIRECTOR

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

Locations

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

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Yue Niu, PhD

Role: CONTACT

niuy@fudan.edu.cn

+86 15900493041

Facility Contacts

Yue Niu, PhD

Role: primary

niuy@fudan.edu.cn

+86-15900493041

Other Identifiers

FDUEH-10

Identifier Type: -

Identifier Source: org_study_id