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| Name | Class |
|---|---|
| Medcin Instituto da Pele Ltda | UNKNOWN |
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A unicentric, blind, non-comparative clinical study to evaluate facial and body anti-aging efficacy of a supplement in female participants through clinical, subjective and instrumental evaluations.
A unicentric, blind, non-comparative clinical study to evaluate facial and body anti-aging efficacy of a supplemente in female participants through clinical, subjective and instrumental evaluations.
It will be necessary 33 female participants aged between 35 and 60 years old with signs of aging on the face and neck, complaining of body flaccidity and gynoid lipodystrophy.
The participant will remain in the study for 90 days using the product. Visits will be scheduled in D0, D45 and D90.
Instrumental evaluations: Evaluated on each visit:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Trial | Experimental | 36 participants using the product for 90 days. Aims to evaluate the clinical, subjective and instrumental usage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A power supplement | Dietary Supplement | A dietary supplement containing vitamins and collagen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability in real conditions of use by questionnaire | Evaluate the effectiveness of the investigational product (nutritional supplement) in improving signs of facial and body aging, through clinical, instrumental and subjective evaluations. Confirm in real conditions of use, the absence of risk and irritation and capture feelings of discomfort in the population studied (0 meaning no risk) | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of skin firmness and elasticity using instrumental evaluation - Cutometer | Evaluate the efficacy of the investigational product in improving the firmness and elasticity of the skin through clinical and instrumental evaluations (cutometry) before using the product (D0) and after 45 (D45) and 90 (D90) days of continuous use; | Day 0, Day 45 e Day 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medcin Instituto da Pele | Osasco | São Paulo | 06023-000 | Brazil |
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90 Days
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| Increase of skin hydration using instrumental evaluation - Corneometer | Evaluate the hydration efficacy before using the investigational product D(0) and after 45 (D45) and 90 (D90) days of continuous use through the Corneometer equipment® | Day 0, Day 45 e Day 90 |
| Detection and accuracy of fine lines and wrinkles- Visia | Evaluate the efficacy of the investigational product in improving wrinkles through instrumental evaluations by Visia® before product use (D0) and after 45 (D45) and 90 (D90) days of use continuous | Day 0, Day 45 e Day 90 |
| Increase in dermal thickness and density in the thigh region | Check the increase in dermal thickness and density in the thigh region through Ultrasound Volunson E8 before using the product (D0) and after 90 (D90) days of continuous | Day 0 e Day 90 |
| Subjective efficacy from the participants | Evaluate the perceived efficacy of the product from the participant's point of view through a subjective questionnaire after 45 (D45) e 90 (D90) days of continuous use of the product | Day 45 e Day 90 |
| Acceptability in real conditions of use through dermatological questionnaire | Check the absence of risk of irritation and capture sensations of discomfort from the studied population, through dermatological evaluation criteria. | Day 0, Day 45 e Day 90 |