In total, 72 eligible research participants were recruited in this 56-day study. The participants were divided into two groups-namely the Experimental Group and the Control Group-according to stratified randomization, with 36 participants in each group. Finally, 30 participants in each group were expected to complete the study. In this study, for patients with rosacea accompanied by sensitive skin, differences in repairing effects and other improvements were evaluated after they used LA ROCHE-POSAY CICAPLAST BAUME B5+ and a standard cream for 28 days, as well as differences between the two groups after both groups used LA ROCHE-POSAY CICAPLAST BAUME B5+ for an additional 28 days-via objective instrumental measurements and subjective assessments. Additionally, the safety of the investigational product was evaluated among these individuals.
During the first phase, both the Experimental Group and the Control Group cleanse their face in the morning and evening according to their daily habits, and should maintain their usual cleansing method, product brand, dosage, etc. The Experimental Group uses the investigational product on the whole face (twice a day), while the Control Group uses the placebo product on the whole face (twice a day). Both groups use standard sunscreen in the morning. During the second phase, both groups use the investigational product on the whole face (twice a day) after cleansing according to their daily habits in the morning and evening, and use standard sunscreen in the morning. During the entire test period, research participants are not allowed to use any other facial skin care products except the provided investigational product or placebo, and the standard sunscreen. The measurements will include clinical grading by dermatologists at Baseline (Day 0), Day 14 (after 14 days of application), Day 28 (after 28 days of application), Day 56 (after 56 days of application); Corneometer, Tewameter, pH meter, Chromameter, PeriCam PSI NR, VISIA; and self-grading at Baseline (Day 0), Day 14, Day 28, Day 56. Self-assessment will be conducted at Day0min (immediately after application), Day 14, Day 28, and Day 56. The 10% lactic acid stinging response test will be measured at Baseline (Day 0) and Day 28.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
72
Twice a day (morning and evening) on face
Twice a day (morning and evening) on face
Beijing Sino-German Union Cosmetic Institute Co., Ltd.
Beijing, China
RECRUITINGCorneometer
Skin hydration.The increase of Corneometer value indicates improvement of water content of skin.
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Tewameter
Transepidermal water loss test. The lower value of TEWL indicates the better skin barrier function.
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Chromameter
a\* value. the smaller the value,the less red the skin .
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
pH meter
Skin pH level
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Clinical grading-Clinician's Erythema Assessment
Clinician's Erythema Assessment(CEA).Score from 0 to 4( 0= Smooth; 1= almost smooth;2= Mild;3= Moderate;4= Severe).The smaller the score value, the better.
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Clinical grading-Investigator Global Assessment
Investigator Global Assessment(IGA).Score from 0 to 4( 0= Smooth; 1= almost smooth;2= Mild;3= Moderate;4= Severe).The smaller the score value is, the better.
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Clinical grading-Visual Analogue Scale
Visual Analogue Scale(VAS).Skin dryness(Not dry at all 0- Very dry10),Burning(No burning sensation at all 0- Very burning 10),Stinging(No stinging sensation at all 0- Very stinging 10),Itching(No itching sensation at all 0- Very itching 10) ,Skin tightness(Not tight at all 0- Very tight 10).The smaller the score value, the better.
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Clinical grading-Safety grading
Safety grading (Scaling, Congestion, Swelling, Blister, Infection, Exudation, Pigmentation, Hypopigmentation, Scar,other), The scale are: 0-None, 1-Very mild,2-Mild, 3-Moderate, 4-Severe.If the symptoms worsen, it is necessary to determine whether they are related to the product
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Image analysis
VISIA 7 photos（a\* value,Red area/AOI area\[%\]）. a\* value,Red area/AOI area\[%\], the smaller the value,the less red the skin
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
PeriCam PSI NR
Blood perfusion volume.The higher the degree of blurriness, the greater the amount of blood flow attention; the lower the degree of blurriness, the smaller the amount of blood flow perfusion
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Self-assessment
Self-assessment by subjects on face.The more percentages of "Full agree" \& "Agree"are chosen, the better.
Time frame: Immediately after once application(Timm),Day 14, Day 28, Day 56
Self grading-Global Flushing Severity Score
Global Flushing Severity Score(GFSS).The smaller the score value, the better.
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Self grading-Patient's Self-assessment Scale
Patient's Self-assessment Scale(PSA).The smaller the score value, the better. Score from 0 to 4( 0= Smooth; 1= almost smooth;2= Mild;3= Moderate;4= Severe).The smaller the score value, the better.
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Self grading-Rosacea-specific quality of life
Rosacea-specific quality of life(Rosa QOL).The smaller the total score, the better
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Self grading-Dermatology Life Quality Index
Dermatology Life Quality Index(DLQI).The smaller the total score, the better
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Self grading-The Sensitive Scale 14
The Sensitive Scale 14(SS14),The smaller the total score, the better
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
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