Recruiting

Cicaplast Baume B5+ for Rosacea with Sensitive Skin

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What is being tested

CICAPLAST BAUME B5+

+ Standard cream

Other
Who is being recruted

From 18 to 55 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Placebo-Controlled
Interventional
Study Start: June 2025
See protocol details

Summary

Principal SponsorBeijing Sino-German Union Cosmetic Institute Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 10, 2025

Actual date on which the first participant was enrolled.

This study aims to evaluate the safety and effectiveness of a product called LA ROCHE-POSAY CICAPLAST BAUME B5+ for people with rosacea and sensitive skin. Rosacea is a common skin condition that causes redness and visible blood vessels on the face, which can be uncomfortable and affect self-esteem. Finding a safe and effective treatment for rosacea, especially for those with sensitive skin, is important because current options may not work for everyone or could cause irritation. By testing this product, the study hopes to provide a new option for people dealing with these skin concerns. Participants in the study will be divided into two groups. In the first phase, one group will apply the investigational product to their entire face twice a day, while the other group will use a placebo, which is a non-active version of the product, twice a day. Both groups will also use a standard sunscreen each morning. In the second phase, all participants will use the investigational product twice a day. Dermatologists will check the skin's condition at the start (Day 0) and then again on days 14, 28, and 56. Participants will also assess their own skin's condition at these times. Various tools will measure skin moisture, pH levels, and other factors, and a test for skin sensitivity will be done at the beginning and on Day 28. This thorough approach helps ensure the study gathers detailed information about how the product affects the skin.

Official TitleA 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
NCT07106957
Principal SponsorBeijing Sino-German Union Cosmetic Institute Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

72 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate
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

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7 exclusion criteria prevent from participating
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.)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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 II

Placebo
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).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

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

Beijing, ChinaOpen Beijing Sino-German Union Cosmetic Institute Co., Ltd. in Google Maps
Recruiting
One Study Center