NCT07521462

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: ISISPHARMA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Rosacea, Erythematotelangiectatic
• Rosacea Subtype 1 (Erythematotelangiectatic)

Interventions

Type	Name	Description
OTHER	Dermocosmetic tested product	The dermocosmetic product will be applied topically to one side of the face twice daily.
OTHER	Placebo	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.
DEVICE	Vascular laser treatment	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.

Timeline

• Start date: 2026-09-01
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2026-04-13
• Last updated: 2026-04-13