NCT06932419

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

April 28, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2026

Completed
Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

April 10, 2025

Last Update Submit

February 28, 2026

Conditions

Skin Health

Keywords

Ozone reaction productsSkin health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Changes in skin hydration

    Immediately before exposure, immediately after exposure, and 24 hours after exposure.

  • Changes in TEWL

    Immediately before exposure, immediately after exposure, and 24 hours after exposure.

  • Changes in pH

    Immediately before exposure, immediately after exposure, and 24 hours after exposure.

Other Outcomes (8)

  • Differences in skin microbiome

    Immediately after exposure.

  • Changes in IL-1α

    Immediately before exposure and immediately after exposure.

  • Changes in IL-1RA

    Immediately before exposure, and immediately after exposure.

  • +5 more other outcomes

Study Arms (2)

Exposure group

EXPERIMENTAL

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

Other: Ozone exposure

Control group

SHAM COMPARATOR

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

Other: Clean air exposure

Interventions

Ozone exposureOTHER

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.

Exposure group
Clean air exposureOTHER

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

Control group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Living in Shanghai during the study period;
  • Having healthy skin conditions on both forearms.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200032, China

Location

Study Officials

  • Yue Niu, PhD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 10, 2025

First Posted

April 17, 2025

Study Start

April 28, 2025

Primary Completion

January 28, 2026

Study Completion

January 28, 2026

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)