Dermocosmetic tested product
OtherThe dermocosmetic product will be applied topically to one side of the face twice daily.
NCT Number: NCT07521462
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The dermocosmetic product will be applied topically to one side of the face twice daily.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Amelie CLEMENT, Engineering degree
CONTACT
Chloe GOYET, Master degree
CONTACT
ISISPHARMA
Industry
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.
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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