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

N/ANot Yet RecruitingNCT07521462

ISISPHARMA50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Efficacy of the dermocosmetic product

To evaluate the efficacy of the dermocosmetic product when used as a monotherapy and following laser treatment on visible microvessels and facial redness associated with rosacea.

Time frame: From enrollment to the end of treatment at 8 months

Secondary Outcomes

Tolerance

To evaluate the tolerability and cosmetic acceptability of the dermocosmetic test product.