Cicaplast Baume B5+ for rosacea with sensitive, dry 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
This trial will see if applying Cicaplast Baume B5+ twice daily reduces redness and sensitivity and improves skin barrier in adults (18–55) with erythematous telangiectatic rosacea.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Beijing Sino-German Union Cosmetic Institute Co., Ltd. Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07106957 on ClinicalTrials.gov |
What this trial studies
Seventy-two adults with erythematous telangiectatic rosacea and sensitive, dry facial skin are randomized into an experimental group and a control group, 36 each. For the first 28 days the experimental group applies Cicaplast Baume B5+ twice daily while the control group uses a placebo standard cream twice daily; for the second 28 days both groups use Cicaplast Baume B5+ twice daily. Clinical grading by dermatologists, objective instrumental measurements (Corneometer, Tewameter, pH meter, Chromameter, PeriCam PSI NR, VISIA), a 10% lactic acid stinging test, and participant self-assessments are collected at baseline, Day 14, Day 28, and Day 56. Safety and tolerability are monitored throughout the 56-day study period.
Who should consider this trial
Good fit: Ideal participants are adults aged 18–55 with erythematous telangiectatic rosacea, dry sensitive facial skin, CEA score 1–3 and IGA ≤2, who are treatment-free or clinically stable on treatment.
Not a fit: People with more severe rosacea (IGA >2), other active facial skin diseases, pregnant or breastfeeding women, or those with major systemic illness are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the product could reduce persistent redness and sensitivity and improve skin barrier function and comfort for people with rosacea and sensitive dry skin.
How similar studies have performed: Barrier-repair and panthenol-containing topical formulations have shown symptomatic improvement in sensitive or irritated skin in prior studies, but randomized evidence specifically in erythematous telangiectatic rosacea is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing
- Beijing Sino-German Union Cosmetic Institute Co., Ltd. — Beijing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.