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

Condition(s) studied

Investigational drug(s) / intervention(s)

Dermocosmetic tested product: The dermocosmetic product will be applied topically to one side of the face twice daily.

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Change from Baseline in IGA Scores on Each Hemiface at 8 Months — 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.

Trial sites (1)