Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorISISPHARMA
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.).
Trial design
Design model
Single group
Treatments tested in this trial
Dermocosmetic tested product
Other interventionThe dermocosmetic product will be applied topically to one side of the face twice daily.
Placebo
Other interventionThe 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.
Vascular laser treatment
DeviceParticipants 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Split-Face dermocosmeticExperimental treatment 2 interventions
Group B: Split-Face placeboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change from Baseline in IGA Scores on Each Hemiface 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 monthsSecondary outcomes
1
Tolerance of the tested product after laser session
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 months2
Change from Baseline in TroSA Score on Each Hemiface 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.
Time frame
From enrollment to the end of treatment at 8 months Source ClinicalTrials.gov