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

Official 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.

Overview

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.

Interventions

• 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.

Primary outcome measures

• Change from Baseline in IGA Scores on Each Hemiface at 8 Months [Time frame: From enrollment to the end of treatment at 8 months]

Secondary outcome measures (2)

• Tolerance of the tested product after laser session [Time frame: From enrollment to the end of treatment at 8 months]
• Change from Baseline in TroSA Score on Each Hemiface at 8 Months [Time frame: From enrollment to the end of treatment at 8 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Single group

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Schaller M, Almeida LMC, Bewley A, Cribier B, Del Rosso J, Dlova NC, Gallo RL, Granstein RD, Kautz G, Mannis MJ, Micali G, Oon HH, Rajagopalan M, Steinhoff M, Tanghetti E, Thiboutot D, Troielli P, Webster G, Zierhut M, van Zuuren EJ, Tan J. Recommendations for rosacea diagnosis, classification and management: update from the global ROSacea COnsensus 2019 panel. Br J Dermatol. 2020 May;182(5):1269- PMID 31392722
• Chajra H, Nadim M, Auriol D, Schweikert K, Lefevre F. Combination of new multifunctional molecules for erythematotelangiectatic rosacea disorder. Clin Cosmet Investig Dermatol. 2015 Oct 1;8:501-10. doi: 10.2147/CCID.S92326. eCollection 2015. PMID 26491365
• Kowalska A, Kalinowska-Lis U. 18beta-Glycyrrhetinic acid: its core biological properties and dermatological applications. Int J Cosmet Sci. 2019 Aug;41(4):325-331. doi: 10.1111/ics.12548. Epub 2019 Jun 28. PMID 31166601
• Cribier B. Rosacea: Treatment targets based on new physiopathology data. Ann Dermatol Venereol. 2022 Jun;149(2):99-107. doi: 10.1016/j.annder.2021.11.001. Epub 2021 Dec 8. PMID 34893359
• Schaller M, Almeida LM, Bewley A, Cribier B, Dlova NC, Kautz G, Mannis M, Oon HH, Rajagopalan M, Steinhoff M, Thiboutot D, Troielli P, Webster G, Wu Y, van Zuuren E, Tan J. Rosacea treatment update: recommendations from the global ROSacea COnsensus (ROSCO) panel. Br J Dermatol. 2017 Feb;176(2):465-471. doi: 10.1111/bjd.15173. Epub 2017 Feb 5. PMID 27861741
• Tan J, Almeida LM, Bewley A, Cribier B, Dlova NC, Gallo R, Kautz G, Mannis M, Oon HH, Rajagopalan M, Steinhoff M, Thiboutot D, Troielli P, Webster G, Wu Y, van Zuuren EJ, Schaller M. Updating the diagnosis, classification and assessment of rosacea: recommendations from the global ROSacea COnsensus (ROSCO) panel. Br J Dermatol. 2017 Feb;176(2):431-438. doi: 10.1111/bjd.15122. Epub 2017 Jan 23. PMID 27718519

Identifiers

NCT: NCT07521462 · RB_2025-01 · 2025-A00892-47

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗