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

Official title

A Single-center, Randomized, Double-blind, Controlled Study Lasting for 56 Days to Evaluate the Safety and Efficacy of LA ROCHE-POSAY CICAPLAST BAUME B5+ in Individuals With Rosacea Accompanied by Sensitive Skin

Overview

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.

Interventions

• Other CICAPLAST BAUME B5+
  Twice a day (morning and evening) on face
• Other Standard cream
  Twice a day (morning and evening) on face

Primary outcome measures

• Corneometer [Time frame: Baseline(Day 0), Day 14, Day 28, Day 56]
• Tewameter [Time frame: Baseline(Day 0), Day 14, Day 28, Day 56]
• Chromameter [Time frame: Baseline(Day 0), Day 14, Day 28, Day 56]
• pH meter [Time frame: Baseline(Day 0), Day 14, Day 28, Day 56]
• Clinical grading-Clinician's Erythema Assessment [Time frame: Baseline(Day 0), Day 14, Day 28, Day 56]
• Clinical grading-Investigator Global Assessment [Time frame: Baseline(Day 0), Day 14, Day 28, Day 56]

Secondary outcome measures (10)

• Clinical grading-Visual Analogue Scale [Time frame: Baseline(Day 0), Day 14, Day 28, Day 56]
• Clinical grading-Safety grading [Time frame: Baseline(Day 0), Day 14, Day 28, Day 56]
• Image analysis [Time frame: Baseline(Day 0), Day 14, Day 28, Day 56]
• PeriCam PSI NR [Time frame: Baseline(Day 0), Day 14, Day 28, Day 56]
• Self-assessment [Time frame: Immediately after once application(Timm),Day 14, Day 28, Day 56]
• Self grading-Global Flushing Severity Score [Time frame: Baseline(Day 0), Day 14, Day 28, Day 56]
• Self grading-Patient's Self-assessment Scale [Time frame: Baseline(Day 0), Day 14, Day 28, Day 56]
• Self grading-Rosacea-specific quality of life [Time frame: Baseline(Day 0), Day 14, Day 28, Day 56]
• Self grading-Dermatology Life Quality Index [Time frame: Baseline(Day 0), Day 14, Day 28, Day 56]
• Self grading-The Sensitive Scale 14 [Time frame: Baseline(Day 0), Day 14, Day 28, Day 56]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

China · 1 center

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

Identifiers

NCT: NCT07106957 · 2025-033-YJ-012

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗