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Ozone Reaction Products and Skin Health

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06932419
Enrollment
40
Registered
2025-04-17
Start date
2025-04-28
Completion date
2026-01-28
Last updated
2026-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Health

Keywords

Ozone reaction products, Skin health

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.

Interventions

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.

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

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in chemical exposome level on the forearm skinImmediately 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

MeasureTime frameDescription
Changes in skin hydrationImmediately 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 TEWLImmediately 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 pHImmediately 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.

Countries

China

Contacts

STUDY_DIRECTORYue Niu, PhD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026