Efficacy and Safety Evaluation of CICAPLAST BAUME B5+ on Rosacea Accompanied by Sensitive Skin

Not Applicable

Recruiting

• Conditions: Erythematous Telangiectatic Rosacea

• Registration Number: NCT07106957
• Lead Sponsor: Beijing Sino-German Union Cosmetic Institute Co., Ltd.

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2025-06-10
• Status Verified: 2025-07
• Study First Submitted: 2025-07-14
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-06
• Last Update Posted: 2025-08-06
• Primary Completion: 2025-08-10
• Study Completion: 2025-08-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Corneometer	Baseline(Day 0), Day 14, Day 28, Day 56	Skin hydration.The increase of Corneometer value indicates improvement of water content of skin.
Tewameter	Baseline(Day 0), Day 14, Day 28, Day 56	Transepidermal water loss test. The lower value of TEWL indicates the better skin barrier function.
Chromameter	Baseline(Day 0), Day 14, Day 28, Day 56	a\* value. the smaller the value,the less red the skin .
pH meter	Baseline(Day 0), Day 14, Day 28, Day 56	Skin pH level
Clinical grading-Clinician's Erythema Assessment	Baseline(Day 0), Day 14, Day 28, Day 56	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.
Clinical grading-Investigator Global Assessment	Baseline(Day 0), Day 14, Day 28, Day 56	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.

Secondary Outcome Measures

Name	Time	Method
Clinical grading-Visual Analogue Scale	Baseline(Day 0), Day 14, Day 28, Day 56	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.
Clinical grading-Safety grading	Baseline(Day 0), Day 14, Day 28, Day 56	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
Image analysis	Baseline(Day 0), Day 14, Day 28, Day 56	VISIA 7 photos（a\* value,Red area/AOI area\[%\]）. a\* value,Red area/AOI area\[%\], the smaller the value,the less red the skin
PeriCam PSI NR	Baseline(Day 0), Day 14, Day 28, Day 56	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
Self-assessment	Immediately after once application(Timm),Day 14, Day 28, Day 56	Self-assessment by subjects on face.The more percentages of "Full agree" \& "Agree"are chosen, the better.
Self grading-Global Flushing Severity Score	Baseline(Day 0), Day 14, Day 28, Day 56	Global Flushing Severity Score(GFSS).The smaller the score value, the better.
Self grading-Patient's Self-assessment Scale	Baseline(Day 0), Day 14, Day 28, Day 56	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.
Self grading-Rosacea-specific quality of life	Baseline(Day 0), Day 14, Day 28, Day 56	Rosacea-specific quality of life(Rosa QOL).The smaller the total score, the better
Self grading-Dermatology Life Quality Index	Baseline(Day 0), Day 14, Day 28, Day 56	Dermatology Life Quality Index(DLQI).The smaller the total score, the better
Self grading-The Sensitive Scale 14	Baseline(Day 0), Day 14, Day 28, Day 56	The Sensitive Scale 14(SS14),The smaller the total score, the better

Trial Locations

Locations (1)

Beijing Sino-German Union Cosmetic Institute Co., Ltd.; 🇨🇳 Beijing, China