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

NCT ID: NCT07106957

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-10
• Study Completion Date: 2025-08-10

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.

Conditions

Erythematous Telangiectatic Rosacea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

LA ROCHE-POSAY CICAPLAST BAUME B5+

During the first phase, after washing the face, the CICAPLAST BAUME B5+ group applies CICAPLAST BAUME B5+ on the whole face twice a day (morning and evening). During the second phase, after washing the face, both the CICAPLAST BAUME B5+ group and the standard cream group apply CICAPLAST BAUME B5+ on the whole face twice a day (morning and evening).

Group Type: EXPERIMENTAL

CICAPLAST BAUME B5+

Intervention Type: OTHER

Twice a day (morning and evening) on face

Standard cream

During the first phase,after wash face,Standard cream group apply the standard cream on whole face twice a day(morning and evening).During the second phase,after wash face, CICAPLAST BAUME B5+ group and standard cream apply the CICAPLAST BAUME B5+ on whole face twice a day(morning and evening).

Group Type: PLACEBO_COMPARATOR

Standard cream

Intervention Type: OTHER

Twice a day (morning and evening) on face

Interventions

CICAPLAST BAUME B5+

Twice a day (morning and evening) on face

Intervention Type: OTHER

Standard cream

Twice a day (morning and evening) on face

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18-55 years old
• Participants in the rosacea erythematous telangiectasia study or participants in the rosacea erythematous telangiectasia study who have not received treatment or have received treatment but are currently in a stable state (no treatment required). The treatment includes local medication, oral medication, phototherapy, or combined therapy
• The score of the Persistent Erythema Assessment Scale (CEA) is between 1 and 3 points
• The score of the Global Assessment Scale (IGA) is ≤2 points
• Dry facial skin
• People with sensitive skin (10% of those sensitive to lactic acid stinging)

Exclusion Criteria

• Intending to get pregnant, pregnant, lactating or within 6 months of delivery
• Research participants with other facial skin diseases (such as seborrheic dermatitis, systemic lupus erythematosus, facial miliform lupus, contact dermatitis, hormone-dependent dermatitis, etc.)
• Systemic diseases accompanied by severe organ damage, malignant tumors, chronic diseases with unstable control, acute infectious diseases, major surgeries or traumas, psychological and mental disorders, or other diseases that require local or systemic use of drugs or treatments that have an impact on acne
• The test area is accompanied by other skin diseases (dermatitis, eczema, infection, tumor, etc.) or has other skin conditions that interfere with evaluation (birthmarks, scars, etc.)
• Received physical, chemical or laser cosmetic surgery that is not for rosacea treatment within 3 months
• Subject who has participated in any clinical test during the past 2 month
• Others whose participation in the study is determined inappropriate by the dermatologist

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Sino-German Union Cosmetic Institute Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Sino-German Union Cosmetic Institute Co., Ltd.

Beijing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Zheng Hongyan

Role: primary

zheng.hongyan@caiq-schrader.com.cn

086 13810897322

Other Identifiers

2025-033-YJ-012

Identifier Type: -

Identifier Source: org_study_id