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

NCT07106957 | Recruiting

• 1 other identifier: 2025-033-YJ-012
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erythematous Telangiectatic Rosacea

Outcome Measures

Primary Outcomes (6)

• Corneometer

  Skin hydration.The increase of Corneometer value indicates improvement of water content of skin.

  Baseline(Day 0), Day 14, Day 28, Day 56

• Tewameter

  Transepidermal water loss test. The lower value of TEWL indicates the better skin barrier function.

  Baseline(Day 0), Day 14, Day 28, Day 56

• Chromameter

  a\* value. the smaller the value,the less red the skin .

  Baseline(Day 0), Day 14, Day 28, Day 56

• pH meter

  Skin pH level

  Baseline(Day 0), Day 14, Day 28, Day 56

• Clinical grading-Clinician's Erythema Assessment

  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.

  Baseline(Day 0), Day 14, Day 28, Day 56

• Clinical grading-Investigator Global Assessment

  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.

  Baseline(Day 0), Day 14, Day 28, Day 56

Secondary Outcomes (10)

• Clinical grading-Visual Analogue Scale

  Baseline(Day 0), Day 14, Day 28, Day 56

• Clinical grading-Safety grading

  Baseline(Day 0), Day 14, Day 28, Day 56

• Image analysis

  Baseline(Day 0), Day 14, Day 28, Day 56

• PeriCam PSI NR

  Baseline(Day 0), Day 14, Day 28, Day 56

• Self-assessment

  Immediately after once application(Timm),Day 14, Day 28, Day 56

Study Arms (2)

LA ROCHE-POSAY CICAPLAST BAUME B5+

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).

Other: CICAPLAST BAUME B5+

Standard cream

PLACEBO COMPARATOR

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).

Other: Standard cream

Interventions

CICAPLAST BAUME B5+ OTHER

Twice a day (morning and evening) on face

LA ROCHE-POSAY CICAPLAST BAUME B5+

Standard cream OTHER

Twice a day (morning and evening) on face

Standard cream

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Beijing, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 6, 2025
• Study Start: June 10, 2025
• Primary Completion: August 10, 2025
• Study Completion: August 10, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-07

Locations

CN (1)