Erythematous Telangiectatic RosaceaNCT07106957
Efficacy and Safety Evaluation of CICAPLAST BAUME B5+ on Rosacea Accompanied by Sensitive Skin
A study testing CICAPLAST BAUME B5+ and Standard cream in people with Erythematous Telangiectatic Rosacea, run by Beijing Sino-German Union Cosmetic Institute Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Erythematous Telangiectatic Rosacea
- What is being tested?
- CICAPLAST BAUME B5+ and Standard cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2025to 10 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Sino-German Union Cosmetic Institute Co., Ltd.
Beijing
Zheng Hongyan, 086 13810897322, zheng.hongyan@caiq-schrader.com.cn
About this study
Official title: 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
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.
Read the detailed description
During the first phase, both the Experimental Group and the Control Group cleanse their face in the morning and evening according to their daily habits, and should maintain their usual cleansing method, product brand, dosage, etc. The Experimental Group uses the investigational product on the whole face (twice a day), while the Control Group uses the placebo product on the whole face (twice a day). Both groups use standard sunscreen in the morning. During the second phase, both groups use the investigational product on the whole face (twice a day) after cleansing according to their daily habits in the morning and evening, and use standard sunscreen in the morning. During the entire test period, research participants are not allowed to use any other facial skin care products except the provided investigational product or placebo, and the standard sunscreen.
The measurements will include clinical grading by dermatologists at Baseline (Day 0), Day 14 (after 14 days of application), Day 28 (after 28 days of application), Day 56 (after 56 days of application); Corneometer, Tewameter, pH meter, Chromameter, PeriCam PSI NR, VISIA; and self-grading at Baseline (Day 0), Day 14, Day 28, Day 56. Self-assessment will be conducted at Day0min (immediately after application), Day 14, Day 28, and Day 56. The 10% lactic acid stinging response test will be measured at Baseline (Day 0) and Day 28.
- Conditions
- Erythematous Telangiectatic Rosacea
- Being tested
- CICAPLAST BAUME B5+, Standard cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CICAPLAST BAUME B5+Other
Twice a day (morning and evening) on face
Standard creamOther
Twice a day (morning and evening) on face
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Standard cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneometer
Skin hydration.The increase of Corneometer value indicates improvement of water content of skin.
Measured: 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.
Measured: Baseline(Day 0), Day 14, Day 28, Day 56
Chromameter
a* value. the smaller the value,the less red the skin .
Measured: Baseline(Day 0), Day 14, Day 28, Day 56
pH meter
Skin pH level
Measured: 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.
Measured: 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.
Measured: Baseline(Day 0), Day 14, Day 28, Day 56
Secondary outcomes (10)
Clinical grading-Visual Analogue Scale
Visual Analogue Scale(VAS).Skin dryness(Not dry at all 0- Very dry10),Burning(No burning sensation at all 0- Very burning 10),Stinging(No stinging sensation at all 0- Very stinging 10),Itching(No itching sensation at all 0- Very itching 10) ,Skin tightness(Not tight at all 0- Very tight 10).The smaller the score value, the better.
Measured: Baseline(Day 0), Day 14, Day 28, Day 56
Clinical grading-Safety grading
Safety grading (Scaling, Congestion, Swelling, Blister, Infection, Exudation, Pigmentation, Hypopigmentation, Scar,other), The scale are: 0-None, 1-Very mild,2-Mild, 3-Moderate, 4-Severe.If the symptoms worsen, it is necessary to determine whether they are related to the product
Measured: Baseline(Day 0), Day 14, Day 28, Day 56
Image analysis
VISIA 7 photos（a* value,Red area/AOI area[%]）. a* value,Red area/AOI area[%], the smaller the value,the less red the skin
Measured: Baseline(Day 0), Day 14, Day 28, Day 56
PeriCam PSI NR
Blood perfusion volume.The higher the degree of blurriness, the greater the amount of blood flow attention; the lower the degree of blurriness, the smaller the amount of blood flow perfusion
Measured: Baseline(Day 0), Day 14, Day 28, Day 56
Self-assessment
Self-assessment by subjects on face.The more percentages of "Full agree" \& "Agree"are chosen, the better.
Measured: Immediately after once application(Timm),Day 14, Day 28, Day 56
Self grading-Global Flushing Severity Score
Global Flushing Severity Score(GFSS).The smaller the score value, the better.
Measured: Baseline(Day 0), Day 14, Day 28, Day 56
Self grading-Patient's Self-assessment Scale
Patient's Self-assessment Scale(PSA).The smaller the score value, the better. Score from 0 to 4( 0= Smooth;
1= almost smooth;2= Mild;3= Moderate;4= Severe).The smaller the score value, the better.
Measured: Baseline(Day 0), Day 14, Day 28, Day 56
Self grading-Rosacea-specific quality of life
Rosacea-specific quality of life(Rosa QOL).The smaller the total score, the better
Measured: Baseline(Day 0), Day 14, Day 28, Day 56
Self grading-Dermatology Life Quality Index
Dermatology Life Quality Index(DLQI).The smaller the total score, the better
Measured: Baseline(Day 0), Day 14, Day 28, Day 56
Self grading-The Sensitive Scale 14
The Sensitive Scale 14(SS14),The smaller the total score, the better
Measured: Baseline(Day 0), Day 14, Day 28, Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start10 Jun 2025
- Primary completion10 Aug 2025 (estimated)
- Study completion10 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythematous Telangiectatic RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Sino-German Union Cosmetic Institute Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106957
- Sponsor's protocol ID
- 2025-033-YJ-012
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07106957
- Acronym / sponsor ID
- 2025-033-YJ-012
- Conditions
- Erythematous Telangiectatic Rosacea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Beijing Sino-German Union Cosmetic Institute Co., Ltd.University, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 10 Aug 2025 (estimated)
- Study completion
- 10 Aug 2025 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
During the first phase, both the Experimental Group and the Control Group cleanse their face in the morning and evening according to their daily habits, and should maintain their usual cleansing method, product brand, dosage, etc. The Experimental Group uses the investigational product on the whole face (twice a day), while the Control Group uses the placebo product on the whole face (twice a day). Both groups use standard sunscreen in the morning. During the second phase, both groups use the investigational product on the whole face (twice a day) after cleansing according to their daily habits in the morning and evening, and use standard sunscreen in the morning. During the entire test period, research participants are not allowed to use any other facial skin care products except the provided investigational product or placebo, and the standard sunscreen.
The measurements will include clinical grading by dermatologists at Baseline (Day 0), Day 14 (after 14 days of application), Day 28 (after 28 days of application), Day 56 (after 56 days of application); Corneometer, Tewameter, pH meter, Chromameter, PeriCam PSI NR, VISIA; and self-grading at Baseline (Day 0), Day 14, Day 28, Day 56. Self-assessment will be conducted at Day0min (immediately after application), Day 14, Day 28, and Day 56. The 10% lactic acid stinging response test will be measured at Baseline (Day 0) and Day 28.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LA ROCHE-POSAY CICAPLAST BAUME B5+ | Experimental | Other: CICAPLAST BAUME B5+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). |
| Standard cream | Placebo comparator | Other: Standard creamDuring 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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CICAPLAST BAUME B5+Twice a day (morning and evening) on face | Other | LA ROCHE-POSAY CICAPLAST BAUME B5+ |
| Standard creamTwice a day (morning and evening) on face | Other | Standard cream |
Primary outcome
Corneometer
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Skin hydration.The increase of Corneometer value indicates improvement of water content of skin.
Tewameter
Time frame: 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
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
a* value. the smaller the value,the less red the skin .
pH meter
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Skin pH level
Clinical grading-Clinician's Erythema Assessment
Time frame: 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
Time frame: 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.
10 secondary outcomes
Clinical grading-Visual Analogue Scale
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Clinical grading-Safety grading
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Image analysis
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
PeriCam PSI NR
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Self-assessment
Time frame: Immediately after once application(Timm),Day 14, Day 28, Day 56
Self grading-Global Flushing Severity Score
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Self grading-Patient's Self-assessment Scale
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Self grading-Rosacea-specific quality of life
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Self grading-Dermatology Life Quality Index
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Self grading-The Sensitive Scale 14
Time frame: Baseline(Day 0), Day 14, Day 28, Day 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
Related trials for Erythematous Telangiectatic Rosacea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beijing Sino-German Union Cosmetic Institute Co., Ltd.
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CICAPLAST BAUME B5+ and Standard cream in people with Erythematous Telangiectatic Rosacea, run by Beijing Sino-German Union Cosmetic Institute Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneometer (time frame: Baseline(Day 0), Day 14, Day 28, Day 56). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.