Dermocosmetic treatment for facial redness in rosacea with or without laser therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests a dermocosmetic product for safety and effectiveness in reducing facial redness and visible vessels in adults with erythematotelangiectatic rosacea. It uses a randomized, double-blind, placebo-controlled, intra-individual design where each participant receives the active product on one side of the face and placebo on the other, with visits over up to 8 months. Participants may also receive vascular laser treatment as part of the protocol, allowing assessment of the product alone and in combination with laser therapy. Outcomes include clinical assessments of redness and telangiectasia, standardized scales, and patient-reported measures, along with safety monitoring for local tolerability and adverse events. The trial is single-center, conducted at CHU de Rouen, with 50 adult participants and led by ISISPHARMA as sponsor.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU de Rouen
  Rouen, France Recruiting

Study contacts

• Principal investigator: Olivia BAUVIN, Doctor of Medicine — Department of Dermatology and Venereology, Charles-Nicolle Hospital, Rouen, FRANCE
• Study coordinator: Chloe GOYET, Master degree
• Email: cgoyet@isispharma.com
• Phone: +33 627806219

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transcutaneous Auricular Vagus Nerve Stimulation for Rosacea

  A small, single-arm pilot study will test whether taVNS can help adults with rosacea and moderate flushing or redness.

  Recruiting Brigham and Women's Hospital · Boston, Massachusetts · NCT07600424

• Treatment of rosacea using radiofrequency microneedling

  This study is testing if using radiofrequency microneedling, alone or with a special laser, can help adults with rosacea feel better and improve their skin.

  Recruiting University of Miami · Miami Beach, Florida · NCT06801717

• Topical anti-inflammatory plus yellow light with tofacitinib and doxycycline for mild to moderate erythematotelangiectatic rosacea

  This trial will try combining a topical anti-inflammatory regimen (Hirudoid followed by yellow light therapy) with the oral medicines tofacitinib and doxycycline to see if it helps Chinese adults with mild to moderate erythematotelangiectatic rosacea.

  Recruiting The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Yiwu, Zhejiang · NCT07343635

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.