Phase
Condition
Rosacea
Scleroderma
Hot Flash
Treatment
Placebo
SCARCr tester 1
Clinical Study ID
Ages 18-65 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject with facial vascular rosacea with flushing, permanent redness,telangiectasias and at least 3 papules and/or pustules (this last criterion for atleast 10 subjects per group)
Subject starting local treatment for rosacea (Ivermectin or metronidazole)
Female aged 18 to 65 years old,
Subject of all types of skin
Subject of I to IV phototype.
Subject accepting not to use any type of facial skin care other than the studyproduct
Subject willing to keep their usual habits and products (hygiene products,sunscreen, and make-up, if applicable)
Subject willing to avoid sun exposure during the study period
Subject willing to actively participate in the study and to come to the scheduledvisits
Subject that has signed informed consent
Exclusion
Exclusion Criteria:
Pregnant or breastfeeding woman
Subject showing cutaneous marks on the experimental areas, which could interferewith the assessment of skin reactions (pigmentation troubles, scar elements,over-developed pilosity, ephelides and naevi in too great quantity, sunburn)
Subject with documented allergy or reactivity to products of the same category thanthe tested one
Subject with documented allergies to study product components
Subject with history of malignant melanomas (Dubreuilh melanosis...)
Subject with unbalanced hormonal treatment
Subject with forecast of initiation of a hormonal treatment or change of the usualhormonal treatment during the study period
Subject with forecast of sun or UVA exposure (UV lamps) during the study period
Subject not willing to use sun protective clothes orhat if exposed to the sun
Subject not willing to respect the methods of use of the treatment, study productand sunscreen
Subject with anti-ageing or aesthetic treatment during the last 6 months: botox orbotox like products, peelings, plastic surgery, hyaluronic acid treatment, PlasmaRich Platelets treatment, or any other specific treatments prone to change the skinaspect
Subject with antibiotic, anti-allergic, anti-inflammatory treatment or treatmentwith patent medicines containing Vitamin A acid or its derivatives within 4 weeksand during the study (if therapeutic requirement: exclusion foreseen),
Subject with systemic disorder: cardiovascular, pulmonary, digestive, neurologic,psychiatric, genital, urinary, haematological, endocrine
Subject presenting chronic diseases with impact on skin
Subject who has undergone a bilateral mastectomy with lymph node removal, aunilateral mastectomy with lymph node removal within the last year, or a bilateralaxillary lymph node removal,
Subject with a history of immune deficiency or auto-immune disease, treated formalignancy within 6 months prior to enrolment or who are currently under treatmentfor asthma or diabetes, forecast of vaccination during the test period or lastvaccination within 3 weeks before the study.
Subject receiving local treatment for rosacea (cyclins, isotretinoin) or who hasundergone local active treatment for rosacea (erythromycin, metronidazole, benzoylperoxide, ivermectin) within 4 weeks before inclusion in the study
Subject who has had oral treatment with metronidazole or cyclins within 4 weeksbefore inclusion in the study
Subject who has had topical or oral anti-inflammatory and/or antiallergy treatment (corticosteroid, antihistamine, anti-inflammatory drugs, immunosuppressives) within 4 weeks before inclusion in the study
Subject who has had oral treatment with retinoids within 2 months before inclusionin the study
Subject currently receiving electrocoagulation or laser treatment for telangiectasia
Study Design
Study Description
Connect with a study center
Cirec Latam
Ciudad Autónoma de Buenos Aire, 1426
ArgentinaSite Not Available
MEDCIN
São Paulo, 01311-000
BrazilSite Not Available
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