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Serum Instant Anti-Redness Efficacy Clinical Study

NCT07058701 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-07-10

No results posted yet for this study

Summary

This study is a mono-centric, om-site use, random half-face application, blank control study. 64 female adult subjects will be enrolled and divided into 2 groups in the study, recruited according to inclusion and non-inclusion criteria listed above. At least 30 subjects for each group should complete the test in this 1 visit study.

Conditions

  • Female
  • Redness

Interventions

OTHER

Investigational Serum, Standard Cleanser

Mode of Group Serum application : On-site single use Standard cleanser + Investigational Serum (random half-face) \[FLA #2039128 50\] \- subjects should wash face with standard cleanser \[FLA #730457 36\] on site before measurements. The technician will apply the Investigational Serum \[FLA #2039128 50\] on the subject's half face (according to the Annex 11.6) at the test site, keep another half face as blank control.

DEVICE

Infrared Light for Redness Induction on Face

Infrared light has high radiation frequency, its permeability is strong, the wavelength of infrared light can penetrate the human dermis to promote blood circulation and induce skin redness.The redness induction process will be done after baseline measurements for each subject.The subject's face was exposed at a distance of 20cm from infrared lamp for minimum 5 - 10 minutes at a temperature of 30-40°C and a wavelength of 760-5000 nm. In general, the skin will not be burned during the induction process. Due to individual differences, if the subjects cannot tolerate or feel uncomfortable during the process, the investigators will stop the process according to the situation; If there is any burn during the process, the on-site dermatologist will treat it in time, and the subject needs to follow the dermatologist's advice for follow-up treatment. Infrared light type: PHILIPS, IR250 RH IR2, 230-250V, 250W, wave length 760-5000nm, T 30\~40°C

Sponsors & Collaborators

  • ChinaNorm

    lead INDUSTRY

Principal Investigators

  • Ping Xu · Shanghai China-norm Quality Technical Service Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-22
Primary Completion
2024-04-24
Completion
2024-05-17

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07058701 on ClinicalTrials.gov