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NCT Number: NCT07521462

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dermocosmetic tested product

Other

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

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.

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.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Tolerance of the tested product after laser session

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

    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.

  2. Change from Baseline in TroSA Score on Each Hemiface at 8 Months

    Time frame: From enrollment to the end of treatment 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amelie CLEMENT, Engineering degree

CONTACT

[email protected]

+33 6 29 76 53 54

Chloe GOYET, Master degree

CONTACT

[email protected]

+33 627806219

Sponsors and collaborators

Lead sponsor

ISISPHARMA

Industry

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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