Clinical trial NCT06932419: Ozone Reaction Products and Skin Health
Official title: Ozone Reaction Products and Their Acute Effects on Skin Health: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Skin Health
Keywords: Ozone reaction products
Skin health
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Changes in chemical exposome level on the forearm skin
timeFrame: Immediately before exposure and immediately after exposure.
Secondary outcomes:
measure: Changes in skin hydration
timeFrame: Immediately before exposure, immediately after exposure, and 24 hours after exposure.
measure: Changes in TEWL
timeFrame: Immediately before exposure, immediately after exposure, and 24 hours after exposure.
measure: Changes in pH
timeFrame: Immediately before exposure, immediately after exposure, and 24 hours after exposure.
Other outcomes:
measure: Differences in skin microbiome
timeFrame: Immediately after exposure.
measure: Changes in TNF-α
timeFrame: Immediately before exposure and immediately after exposure.
measure: Changes in IL-1α
timeFrame: Immediately before exposure and immediately after exposure.
measure: Changes in pyrrolidone carboxylic acid
timeFrame: Immediately before exposure, and immediately after exposure.
measure: Changes in total protein levels of stratum corneum
timeFrame: Immediately before exposure, and immediately after exposure.
measure: Changes in carbonyl protein
timeFrame: Immediately before exposure, and immediately after exposure.
measure: Changes in total antioxidant capacity
timeFrame: Immediately before exposure, and immediately after exposure.
measure: Changes in GSH
timeFrame: Immediately before exposure, and immediately after exposure.
Locations:
city: Shanghai
country: China
facility: Department of Environmental Health, School of Public Health, Fudan University
state: Shanghai
Study officials:
affiliation: Department of Environmental Health, School of Public Health, Fudan University
name: Yue Niu, PhD
role: STUDY_DIRECTOR
References: