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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00892-47 | Other Identifier | ANSM (French National Agency for Drug and Health Product Safety) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermocosmetic tested product | Other | The dermocosmetic product will be applied topically to one side of the face twice daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chloe GOYET, Master degree | Contact | +33 627806219 | cgoyet@isispharma.com | |
| Amelie CLEMENT, Engineering degree | Contact | +33 6 29 76 53 54 | aclement@isispharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Olivia BAUVIN, Doctor of Medicine | Department of Dermatology and Venereology, Charles-Nicolle Hospital, Rouen, FRANCE | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31392722 | Background | 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. | |
| 26491365 |
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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.
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| D013684 | Telangiectasis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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| Placebo | Other | 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. |
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| Vascular laser treatment | Device | 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. |
|
| 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. | From enrollment to the end of treatment at 8 months |
| Background |
| Chajra 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. |
| 31166601 | Background | Kowalska 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. |
| 34893359 | Background | Cribier 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. |
| 27861741 | Background | Schaller 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. |
| 27718519 | Background | Tan 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. |