Rosacea, Erythematotelangiectatic, Rosacea Subtype 1 (Erythematotelangiectatic)
Conditions
Keywords
Erythematotelangiectatic Rosacea, Telangiectasia, Dermocosmetic, Laser Therapy
Brief 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.
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
OTHERDermocosmetic tested product
The dermocosmetic product will be applied topically to one side of the face twice daily.
OTHERPlacebo
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.
DEVICEVascular 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.
Sponsors
ISISPHARMA
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Split-Face dermocosmetic and placebo Participants apply dermocosmetic to one side of the face and placebo to the opposite side according to a randomized, double-blind split-face design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance of the tested product after laser session | 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. |
| Change from Baseline in TroSA Score on Each Hemiface at 8 Months | 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. |
Countries
France
Contacts
CONTACTChloe GOYET, Master degree
CONTACTAmelie CLEMENT, Engineering degree
PRINCIPAL_INVESTIGATOROlivia BAUVIN, Doctor of Medicine
Department of Dermatology and Venereology, Charles-Nicolle Hospital, Rouen, FRANCE
Outcome results
None listed