Efficacy and Safety Evaluation of CICAPLAST BAUME B5+ on Rosacea Accompanied by Sensitive Skin
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
Beijing Sino-German Union Cosmetic Institute Co., Ltd.
72 participants
Jun 10, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria7
- 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
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Interventions
Twice a day (morning and evening) on face
Twice a day (morning and evening) on face
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07106957