Status:
COMPLETED
Evaluation of the Efficacy and Tolerance of Two Cosmetic Products in Subjects With Rosacea
Lead Sponsor:
NAOS Argentina S.A.
Conditions:
Rosacea
Redness
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
Multicentric and double-blind randomised comparative clinical study in Argentina and Brazil. Under dermatological and ophthalmological control 4 visits: inclusion \[Day(D)0\], D28, D56, D84 Ethical co...
Detailed Description
Primary objective: To evaluate the efficacy of two cosmetic products (SCARCr tester 1 and SCARCr tester 2) in association to the topical medical treatment (Ivermectin or Metronidazole) in supporting ...
Eligibility Criteria
Inclusion
- Subject with facial vascular rosacea with flushing, permanent redness, telangiectasias and at least 3 papules and/or pustules (this last criterion for at least 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 study product
- 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 scheduled visits
- Subject that has signed informed consent
Exclusion
- Pregnant or breastfeeding woman
- Subject showing cutaneous marks on the experimental areas, which could interfere with 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 than the 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 usual hormonal 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 product and sunscreen
- Subject with anti-ageing or aesthetic treatment during the last 6 months: botox or botox like products, peelings, plastic surgery, hyaluronic acid treatment, Plasma Rich Platelets treatment, or any other specific treatments prone to change the skin aspect
- Subject with antibiotic, anti-allergic, anti-inflammatory treatment or treatment with patent medicines containing Vitamin A acid or its derivatives within 4 weeks and 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, a unilateral mastectomy with lymph node removal within the last year, or a bilateral axillary lymph node removal,
- Subject with a history of immune deficiency or auto-immune disease, treated for malignancy within 6 months prior to enrolment or who are currently under treatment for asthma or diabetes, forecast of vaccination during the test period or last vaccination within 3 weeks before the study.
- Subject receiving local treatment for rosacea (cyclins, isotretinoin) or who has undergone local active treatment for rosacea (erythromycin, metronidazole, benzoyl peroxide, ivermectin) within 4 weeks before inclusion in the study
- Subject who has had oral treatment with metronidazole or cyclins within 4 weeks before 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 inclusion in the study
- Subject currently receiving electrocoagulation or laser treatment for telangiectasia
Key Trial Info
Start Date :
May 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06582043
Start Date
May 16 2024
End Date
February 6 2025
Last Update
February 28 2025
Active Locations (2)
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1
Cirec Latam
Ciudad Autónoma de Buenos Aire, Argentina, 1426
2
MEDCIN
São Paulo, Brazil, 01311-000