Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy

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.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.
• 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.