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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 committee required.
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 the improvement of persistent redness due to rosacea and in soothing discomfort sensations, under dermatological and ophthalmological control.
Secondary objectives:
To evaluate the cutaneous and ocular tolerance of two cosmetic products in subjects presenting with rosacea under treatment with topical Ivermectin or Metronidazole for 56 days, and 28 days after applying the cosmetic products alone. To evaluate the efficacyof two cosmetic products through clinical evaluation of the symptoms related to rosacea after 56 days of concomitant use of the cosmetic product with the topical medical treatment, and 28 days after applying the cosmetic products alone. To evaluate the efficacyof two cosmetic products through instrumental measurements of redness after 56 days of concomitant use of the cosmetic product with the topical medical treatment, and 28 days after applying the cosmetic products alone. To evaluate the evolution of the quality of life of the subjects over the period of use of the association of the topical medical treatment with the cosmetic products (56 days) and 28 days after applying the cosmetic products alone. To evaluate the immediate and long-lasting eCicacy and cosmetic qualities of the cosmetic products based on self-assessment questionnaires by the subjects. To compare the two products tolerance and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCARCr tester 1 | Active Comparator | The subjects will apply the product concomitantly with the topical medical treatment for 56 days, followed by 28 days applying the SCARCr tester 1 alone. Instructions for topical medical treatment and study product application:
Subjects must keep their usual habits during the clinical study (hygiene products, sunscreen, make-up). If the application of sunscreen |
|
| SCARCr tester 2 | Placebo Comparator | The subjects will apply the product concomitantly with the topical medical treatment for 56 days, followed by 28 days applying the SCARCr tester 2 alone. Instructions for topical medical treatment and study product application:
Subjects must keep their usual habits during the clinical study (hygiene products, sunscreen, make-up). If the application of sunscreen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCARCr tester 1 | Other | Twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment (IGA) | 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 the improvement of persistent redness due to rosacea and in soothing discomfort sensations, under dermatological and ophthalmological control (scoring scale from better to worse value: clear, minimal, mild and mild to moderate). | Day 0- Day 28- Day 56- Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Cutaneous and ocular tolerance | Collection of adverse events | Day 0- Day 28- Day 56- Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the quality of life RosaQoL (Rosacea Quality of Life) questionnaire | Scoring scale from better to worse value: never, rarely, sometimes, often and always. Minimum value: never; Maximun value: always. | Day 0- Day 28- Day 56- Day 84 |
| Evolution of the quality of life Mood Pict |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cirec Latam | Ciudad Autónoma de Buenos Aire | 1426 | Argentina | |||
| MEDCIN |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| D004890 | Erythema |
| D013684 | Telangiectasis |
| D005483 | Flushing |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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Multicentric and double-blind randomised comparative clinical study in Argentina and Brazil. Under dermatological and ophthalmological control
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Randomization for product allocation will consider: number of papules/pustules (<3, ≥3), age (18-35, 35-50, >51), phototype (I-III and IV), sun protector (always, sometimes, never)
| Placebo |
| Other |
Twice daily |
|
Scoring scale from better to worse value: not at all, lightly, moderate, a lot and extremely. |
| Day 0- Day 28- Day 56- Day 84 |
| Evolution of the quality of life Feel Pict questionnaires | Scoring scale from better to worse value; low and high. | Day 0- Day 28- Day 56- Day 84 |
| Evaluate the immediate and long-lasting eficacy and cosmetic qualities | Self-assessment questionnaires by the subjects (scoring scale from better to worse value: totally agree, agree, disagree and totally disagree). | Day 0- Day 28- Day 56- Day 84 |
| São Paulo |
| 01311-000 |
| Brazil |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |