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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
65
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.
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
Shanghai China-norm Quality Technical Service Co., Ltd.
Shanghai, Shanghai Municipality, China
Clinical scoring for skin redness
Participants: N= 30
Time frame: Baseline, Time point post-induction 5 min , Time point post-intervention 5 min,Time point post-intervention 1 hour, Time point post-intervention 2 hours.
Clinical scoring for skin redness
Participants: N= 30
Time frame: Baseline, Time point post-induction 5 min.
Image Capture and Analysis(Redness area ratio)
Participants: N= 30,by VISIA 7
Time frame: Baseline, Time point post-induction 5 min , Time point post-intervention 5 min,Time point post-intervention 1 hour, Time point post-intervention 2 hours.
Image Capture and Analysis(Redness area ratio)
Participants: N= 30,by TiVi 700 Tissue Viability Imager
Time frame: Baseline, Time point post-induction 5 min , Time point post-intervention 5 min,Time point post-intervention 1 hour, Time point post-intervention 2 hours.
Instrumental Assessment (Erythema index)
Participants: N= 30, by Mexameter
Time frame: Baseline, Time point post-induction 5 min , Time point post-intervention 5 min,Time point post-intervention 1 hour, Time point post-intervention 2 hours.
Consumer Questionnaire
Participants: N= 60
Time frame: Time point post-intervention 10 sec, Time point post-intervention 1 min, Time point post-intervention 5 min,Time point post-intervention 1 hour, Time point post-intervention 2 hours.
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