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

April 3, 2026 updated by: ISISPHARMA

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Split-Face dermocosmetic
Participants receive both treatments in a split-face design, with the dermocosmetic product applied to one side of the face and placebo applied to the opposite side. Treatments are applied twice daily.
Other: Dermocosmetic tested product
The dermocosmetic product will be applied topically to one side of the face twice daily.
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.
Placebo Comparator: Split-Face placebo
Participants receive both treatments in a split-face design, with the dermocosmetic product applied to one side of the face and placebo applied to the opposite side. Treatments are applied twice daily.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of the dermocosmetic product
Time Frame: From enrollment to the end of treatment at 8 months
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.
From enrollment to the end of treatment at 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance
Time Frame: From enrollment to the end of treatment at 8 months
To evaluate the tolerability and cosmetic acceptability of the dermocosmetic test product.
From enrollment to the end of treatment at 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ISISPHARMA

Investigators

  • Principal Investigator: Olivia BAUVIN, Doctor of Medicine, Department of Dermatology and Venereology, Charles-Nicolle Hospital, Rouen, FRANCE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RB_2025-01
  • 2025-A00892-47 (Other Identifier: ANSM (French National Agency for Drug and Health Product Safety))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to sponsor confidentiality policies and in order to protect participant privacy and comply with applicable data protection regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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