Rosacea, ErythematotelangiectaticNCT07521462
Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
A study testing Dermocosmetic tested product and Vascular laser treatment in people with Rosacea, Erythematotelangiectatic and Rosacea Subtype 1 (Erythematotelangiectatic), run by ISISPHARMA at 1 site in France.
Trial summary
The aim of this clinical study is to evaluate the effectiveness and safety of a dermocosmetic product in reducing facial redness and visible blood vessels associated with erythematotelangiectatic rosacea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea, Erythematotelangiectatic, Rosacea Subtype 1 (Erythematotelangiectatic)
- What is being tested?
- Dermocosmetic tested product and Vascular laser treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2026to 30 Jun 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gender: male or female
- Age: > 18 years -Patients with mild to severe erythro-couperotic rosacea (stage 2, 3, or 4 - TRoSA scale, section 2.2.3.1)
- Patients wishing to undergo vascular laser treatments for their rosacea
- Patients who have provided informed consent
Who cannot join
- Pregnant patients or patients with a positive urine pregnancy test at the initial visit
- Patients with another condition in the study area.
- Patients who have received laser treatment for the same condition within the previous 12 months.
- Patients with another form of rosacea (e.g., papules and pustules, ocular rosacea, etc.).
- Patients using another anti-redness product on the face during the study.
- Patients who have taken photosensitizing treatments during the month prior to study enrollment.
Show all 10Show fewer
- Patients taking or having taken oral isotretinoin within 6 months prior to study enrollment.
- Patients enrolled in another study.
- Adult patients under a legal guardianship arrangement (guardianship, conservatorship, judicial protection).
- Patients not covered by social security.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Rouen
Rouen
Olivia BAUVIN, +33666764095, Olivia.Bauvin@chu-rouen.fr
Olivia BAUVIN, Dr.
About this study
Official title: Impact of Using a Dermocosmetic Product as Monotherapy or as an Adjunct to Laser Treatment on Redness Associated With Erythematotelangiectatic Rosacea: a Comparative Study Versus Placebo.
The aim of this clinical study is to evaluate the effectiveness and safety of a dermocosmetic product in reducing facial redness and visible blood vessels associated with erythematotelangiectatic rosacea.
Investigators will compare the dermocosmetic product to a placebo applied to opposite sides of the face, when used alone and in combination with laser treatment.
Participants will apply the products twice daily for 2 month followed by continued use in combination with laser treatment, and will attend regular clinical visits for assessments and questionnaires.
Read the detailed description
Rosacea is a chronic inflammatory skin condition characterized by facial redness and visible blood vessels, which can significantly impact patients' quality of life. Current management often includes laser or light-based therapies, although these approaches may have limitations.
This study aims to evaluate the efficacy and safety of a dermocosmetic product in reducing facial redness and visible blood vessels associated with erythematotelangiectatic rosacea, when used alone and in combination with laser treatment.
This is a single-center, interventional study (RIPH 2), randomized, double-blind, placebo-controlled, and intra-individual (split-face) design in approximately 50 adult patients.
Participants will apply the dermocosmetic product and placebo to opposite sides of the face over a period of up to 8 months, including use in combination with laser treatment.
Efficacy will be assessed through clinical evaluations of redness and visible blood vessels, supported by standardized assessments and patient-reported outcomes. Safety will be evaluated through monitoring of local tolerability and adverse events.
- Being tested
- Dermocosmetic tested product, Placebo, Vascular laser treatment
- Keywords
- Erythematotelangiectatic Rosacea, Telangiectasia, Dermocosmetic, Laser Therapy
- Medical subject headings
- Rosacea, Telangiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermocosmetic tested productOther
The dermocosmetic product will be applied topically to one side of the face twice daily.
PlaceboOther
The placebo is a dermocosmetic formulation identical in appearance, texture, and application to the active product but without active ingredients. It is applied topically to the opposite side of the face twice daily, following the same regimen as the active product.
Vascular laser treatmentDevice
Participants receive three sessions of vascular laser treatment performed at regular intervals during the study. Laser therapy is used as part of standard care to target facial redness and visible blood vessels. The dermocosmetic product and placebo continue to be applied as adjunct treatments during this phase.
| Study group | Role | What they receive |
|---|---|---|
| Split-Face dermocosmetic | Experimental | Participants receive both treatments in a split-face design, with the dermocosmetic product applied to one side of the face and placebo applied to the opposite side. Treatments are applied twice daily. Receives: Other: Dermocosmetic tested product; Device: Vascular laser treatment |
| Split-Face placebo | Placebo comparator | Participants receive both treatments in a split-face design, with the dermocosmetic product applied to one side of the face and placebo applied to the opposite side. Treatments are applied twice daily. Receives: Other: Placebo; Device: Vascular laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in IGA Scores on Each Hemiface at 8 Months
Efficacy is assessed using three Investigator Global Assessment (IGA) scales evaluated independently on each hemiface: Global IGA, Erythema IGA, and Telangiectasia IGA. Each scale ranges from 0 (clear) to 4 (severe); lower scores indicate better outcome.
Measured: From enrollment to the end of treatment at 8 months
Secondary outcomes (2)
Tolerance of the tested product after laser session
Local and systemic adverse events are assessed at each visit by the investigator. Tolerability is rated on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) for erythema, burning, pruritus, and dryness on each hemiface independently.
Measured: From enrollment to the end of treatment at 8 months
Change from Baseline in TroSA Score on Each Hemiface at 8 Months
TroSA (Telangiectasia Rosacea Score Assessment) is a photographic standardized scale assessing telangiectasia severity on each hemiface independently. Scores range from 0 (Clear) to 4 (severe telangiectasia); lower scores indicate better outcome.
Measured: From enrollment to the end of treatment at 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start3 Sep 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rosacea, ErythematotelangiectaticStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Split-Face dermocosmetic and placebo Participants apply dermocosmetic to one side of the face and placebo to the opposite side according to a randomized, double-blind split-face design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ISISPHARMA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olivia BAUVIN, Doctor of Medicine, Principal investigator, Department of Dermatology and Venereology, Charles-Nicolle Hospital, Rouen, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521462
- Sponsor's protocol ID
- RB_2025-01
- Other IDs
- 2025-A00892-47
- Status last verified
- Sep 2026
- First submitted
- 3 Apr 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to sponsor confidentiality policies and in order to protect participant privacy and comply with applicable data protection regulations.
Publications
Schaller M, Almeida LMC, Bewley A, Cribier B, Del Rosso J, Dlova NC, Gallo RL, Granstein RD, Kautz G, Mannis MJ, Micali G, Oon HH, Rajagopalan M, Steinhoff M, Tanghetti E, Thiboutot D, Troielli P, Webster G, Zierhut M, van Zuuren EJ, Tan J. Recommendations for rosacea diagnosis, classification and management: update from the global ROSacea COnsensus 2019 panel. Br J Dermatol. 2020 May;182(5):1269-1276. doi: 10.1111/bjd.18420. Epub 2019 Oct 16.
PubMed 31392722Chajra H, Nadim M, Auriol D, Schweikert K, Lefevre F. Combination of new multifunctional molecules for erythematotelangiectatic rosacea disorder. Clin Cosmet Investig Dermatol. 2015 Oct 1;8:501-10. doi: 10.2147/CCID.S92326. eCollection 2015.
PubMed 26491365Kowalska A, Kalinowska-Lis U. 18beta-Glycyrrhetinic acid: its core biological properties and dermatological applications. Int J Cosmet Sci. 2019 Aug;41(4):325-331. doi: 10.1111/ics.12548. Epub 2019 Jun 28.
PubMed 31166601Cribier B. Rosacea: Treatment targets based on new physiopathology data. Ann Dermatol Venereol. 2022 Jun;149(2):99-107. doi: 10.1016/j.annder.2021.11.001. Epub 2021 Dec 8.
PubMed 34893359Schaller M, Almeida LM, Bewley A, Cribier B, Dlova NC, Kautz G, Mannis M, Oon HH, Rajagopalan M, Steinhoff M, Thiboutot D, Troielli P, Webster G, Wu Y, van Zuuren E, Tan J. Rosacea treatment update: recommendations from the global ROSacea COnsensus (ROSCO) panel. Br J Dermatol. 2017 Feb;176(2):465-471. doi: 10.1111/bjd.15173. Epub 2017 Feb 5.
PubMed 27861741Tan J, Almeida LM, Bewley A, Cribier B, Dlova NC, Gallo R, Kautz G, Mannis M, Oon HH, Rajagopalan M, Steinhoff M, Thiboutot D, Troielli P, Webster G, Wu Y, van Zuuren EJ, Schaller M. Updating the diagnosis, classification and assessment of rosacea: recommendations from the global ROSacea COnsensus (ROSCO) panel. Br J Dermatol. 2017 Feb;176(2):431-438. doi: 10.1111/bjd.15122. Epub 2017 Jan 23.
PubMed 27718519
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Using a Dermocosmetic Product as Monotherapy or as an Adjunct to Laser Treatment on Redness Associated With Erythematotelangiectatic Rosacea: a Comparative Study Versus Placebo.
- ClinicalTrials.gov ID
- NCT07521462
- Acronym / sponsor ID
- RB_2025-01
- Keywords
- Erythematotelangiectatic Rosacea, Telangiectasia, Dermocosmetic, Laser Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- ISISPHARMAIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Apr 2026 (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.
The aim of this clinical study is to evaluate the effectiveness and safety of a dermocosmetic product in reducing facial redness and visible blood vessels associated with erythematotelangiectatic rosacea.
Investigators will compare the dermocosmetic product to a placebo applied to opposite sides of the face, when used alone and in combination with laser treatment.
Participants will apply the products twice daily for 2 month followed by continued use in combination with laser treatment, and will attend regular clinical visits for assessments and questionnaires.
Detailed description
Rosacea is a chronic inflammatory skin condition characterized by facial redness and visible blood vessels, which can significantly impact patients' quality of life. Current management often includes laser or light-based therapies, although these approaches may have limitations.
This study aims to evaluate the efficacy and safety of a dermocosmetic product in reducing facial redness and visible blood vessels associated with erythematotelangiectatic rosacea, when used alone and in combination with laser treatment.
This is a single-center, interventional study (RIPH 2), randomized, double-blind, placebo-controlled, and intra-individual (split-face) design in approximately 50 adult patients.
Participants will apply the dermocosmetic product and placebo to opposite sides of the face over a period of up to 8 months, including use in combination with laser treatment.
Efficacy will be assessed through clinical evaluations of redness and visible blood vessels, supported by standardized assessments and patient-reported outcomes. Safety will be evaluated through monitoring of local tolerability and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-Face dermocosmetic and placebo Participants apply dermocosmetic to one side of the face and placebo to the opposite side according to a randomized, double-blind split-face design.
| Arm | Type | Receives |
|---|---|---|
| Split-Face dermocosmetic | Experimental | Other: Dermocosmetic tested product, Device: Vascular laser treatmentParticipants receive both treatments in a split-face design, with the dermocosmetic product applied to one side of the face and placebo applied to the opposite side. Treatments are applied twice daily. |
| Split-Face placebo | Placebo comparator | Other: Placebo, Device: Vascular laser treatmentParticipants receive both treatments in a split-face design, with the dermocosmetic product applied to one side of the face and placebo applied to the opposite side. Treatments are applied twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Gender: male or female
- Age: > 18 years -Patients with mild to severe erythro-couperotic rosacea (stage 2, 3, or 4 - TRoSA scale, section 2.2.3.1)
- Patients wishing to undergo vascular laser treatments for their rosacea
- Patients who have provided informed consent
Key exclusion criteria (10 listed)
- Pregnant patients or patients with a positive urine pregnancy test at the initial visit
- Patients with another condition in the study area.
- Patients who have received laser treatment for the same condition within the previous 12 months.
- Patients with another form of rosacea (e.g., papules and pustules, ocular rosacea, etc.).
- Patients using another anti-redness product on the face during the study.
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 |
|---|---|---|
| Dermocosmetic tested productThe dermocosmetic product will be applied topically to one side of the face twice daily. | Other | Split-Face dermocosmetic |
| PlaceboThe placebo is a dermocosmetic formulation identical in appearance, texture, and application to the active product but without active ingredients. It is applied topically to the opposite side of the face twice daily, following the same regimen as the active product. | Other | Split-Face placebo |
| Vascular laser treatmentParticipants receive three sessions of vascular laser treatment performed at regular intervals during the study. Laser therapy is used as part of standard care to target facial redness and visible blood vessels. The dermocosmetic product and placebo continue to be applied as adjunct treatments during this phase. | Device | Split-Face dermocosmetic, Split-Face placebo |
Primary outcome
Change from Baseline in IGA Scores on Each Hemiface at 8 Months
Time frame: From enrollment to the end of treatment at 8 months
Efficacy is assessed using three Investigator Global Assessment (IGA) scales evaluated independently on each hemiface: Global IGA, Erythema IGA, and Telangiectasia IGA. Each scale ranges from 0 (clear) to 4 (severe); lower scores indicate better outcome.
2 secondary outcomes
Tolerance of the tested product after laser session
Time frame: From enrollment to the end of treatment at 8 months
Change from Baseline in TroSA Score on Each Hemiface at 8 Months
Time frame: From enrollment to the end of treatment at 8 months
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 8 Sep 2026.
- Background: PubMed 31392722Schaller M, Almeida LMC, Bewley A, Cribier B, Del Rosso J, Dlova NC, Gallo RL, Granstein RD, Kautz G, Mannis MJ, Micali G, Oon HH, Rajagopalan M, Steinhoff M, Tanghetti E, Thiboutot D, Troielli P, Webster G, Zierhut M, van Zuuren EJ, Tan J. Recommendations for rosacea diagnosis, classification and management: update from the global ROSacea COnsensus 2019 panel. Br J Dermatol. 2020 May;182(5):1269-1276. doi: 10.1111/bjd.18420. Epub 2019 Oct 16.
- Background: PubMed 26491365Chajra H, Nadim M, Auriol D, Schweikert K, Lefevre F. Combination of new multifunctional molecules for erythematotelangiectatic rosacea disorder. Clin Cosmet Investig Dermatol. 2015 Oct 1;8:501-10. doi: 10.2147/CCID.S92326. eCollection 2015.
- Background: PubMed 31166601Kowalska A, Kalinowska-Lis U. 18beta-Glycyrrhetinic acid: its core biological properties and dermatological applications. Int J Cosmet Sci. 2019 Aug;41(4):325-331. doi: 10.1111/ics.12548. Epub 2019 Jun 28.
- Background: PubMed 34893359Cribier B. Rosacea: Treatment targets based on new physiopathology data. Ann Dermatol Venereol. 2022 Jun;149(2):99-107. doi: 10.1016/j.annder.2021.11.001. Epub 2021 Dec 8.
- Background: PubMed 27861741Schaller M, Almeida LM, Bewley A, Cribier B, Dlova NC, Kautz G, Mannis M, Oon HH, Rajagopalan M, Steinhoff M, Thiboutot D, Troielli P, Webster G, Wu Y, van Zuuren E, Tan J. Rosacea treatment update: recommendations from the global ROSacea COnsensus (ROSCO) panel. Br J Dermatol. 2017 Feb;176(2):465-471. doi: 10.1111/bjd.15173. Epub 2017 Feb 5.
- Background: PubMed 27718519Tan J, Almeida LM, Bewley A, Cribier B, Dlova NC, Gallo R, Kautz G, Mannis M, Oon HH, Rajagopalan M, Steinhoff M, Thiboutot D, Troielli P, Webster G, Wu Y, van Zuuren EJ, Schaller M. Updating the diagnosis, classification and assessment of rosacea: recommendations from the global ROSacea COnsensus (ROSCO) panel. Br J Dermatol. 2017 Feb;176(2):431-438. doi: 10.1111/bjd.15122. Epub 2017 Jan 23.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to sponsor confidentiality policies and in order to protect participant privacy and comply with applicable data protection regulations.
Related trials for Rosacea, Erythematotelangiectatic
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea
Rosacea, Rosacea, Erythematotelangiectatic
Recruiting
Rosacea Radiofrequency Microneedling
Rosacea, Papulopustular, Rosacea, Erythematotelangiectatic
Recruiting
The Efficacy and Safety of Anti-inflammation Treatment (Hirudoid Introduction Followed by Yellow Light Therapy) Combined With Tofacitinib and Doxycycline in Chinese Adult Patients With Mild to Moderate Erythematous Telangiectatic Rosacea
Erythematotelangiectatic 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.
Olivia BAUVIN, Doctor of Medicine principal investigator
Department of Dermatology and Venereology, Charles-Nicolle Hospital, Rouen, FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dermocosmetic tested product and Vascular laser treatment in people with Rosacea, Erythematotelangiectatic and Rosacea Subtype 1 (Erythematotelangiectatic), run by ISISPHARMA at 1 site in France.
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 4 inclusion and 10 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 8 Sep 2026. 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 France. 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?
Contact Chloe GOYET, Master degree (+33 627806219, cgoyet@isispharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in IGA Scores on Each Hemiface at 8 Months (time frame: From enrollment to the end of treatment at 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07521462, which also lists 6 linked publications.
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 8 Sep 2026.