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

NCT07106957 · tracked via the Priya Life Science China tracker

Sponsor

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

Phase

Not applicable

Started

2025-06-10

Last updated

2025-08-06

Condition(s) studied

Erythematous Telangiectatic Rosacea

Investigational drug(s) / intervention(s)

CICAPLAST BAUME B5+Standard cream

CICAPLAST BAUME B5+: Twice a day (morning and evening) on face

Standard cream: Twice a day (morning and evening) on face

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

55 Years

Healthy volunteers

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

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Beijing Sino-German Union Cosmetic Institute Co., Ltd.	Beijing	China	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07106957 on ClinicalTrials.gov ↗ ← All trials in China