Clinical Study, Opened, of Cutaneous Acceptability of a Topic Product in Normal Conditions of Use

Study Overview
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Brief Summary
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The measured product in this research is a product for topical use, Laboratoires Mercurochrome Reparador e Protetor. The expected benefit to the use of the product is the improvement in skin hydration as measured by self perception of participant research and clinical evaluation and improvement in local microcirculation, assessed by instrumental measurements in feet of the study participants.

Detailed Description
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The objectives of this study is to verify the skin acceptability through the non-occurrence of adverse events and cutaneous sensations of discomfort, evaluate the moisturizing efficacy of the product through self perception of research participants and dermatological clinical evaluation to assess the improvement in local microcirculation by performing of instrumental measurements in the feet of diabetic participants, product Laboratoires Mercurochrome Repairer and Protector referred by LM FARMA INDUSTRIAL LTDA. For this research, will be recruited up to 35 research participants who meet the inclusion / exclusion described in items 9.4 and 9.5 of the research protocol, to achieve a number of completion of 30 participants. Be recruited participants from both sexes, aged 18 and 65, which have dry skin on the feet and they are people with diabetes whose condition is stabilized.

Official Title
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Clinical Study, Opened, of Cutaneous Acceptability of a Topic Product in Normal Conditions of Use and Evaluation of the Effectiveness Through the Self Awareness of the Research, of Clinical Evaluations and Instrumental Measurements

Conditions
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Diabetes

Intervention / Treatment
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* Device: Laboratoires Mercurochrome Reparador


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants healthy research; Intact skin on feet - grade 0 in the Wagner scale; Agreement to adhere to the procedures and requirements of the study and attend to the Office (s) day (s) and time (s) set (s) for evaluations; Ability to consent to participate in writing; Age 18 to 65 years; Research Participants of both sexes - including at least three men; Introducing dry skin on feet - dermatological proof. Participants with diabetes whose condition is stabilized Exclusion Criteria: Pregnancy and lactation; skin pathology in the product application area; immune impairment; Current use of these medications for topical or systemic use: corticoid, immunosuppressants, antihistamines, anticoagulants or birth; Skin diseases: psoriasis, vitiligo, atopic dermatitis; History of reaction to the category of the product tested; Other diseases or medications that may interfere directly in the study or to endanger the health of the research participant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laboratoires Mercurochrome Reparador<br>A group of patients will be treated with a new restorative skin cream consists of hyperoxygenation essential fatty acids (60% linoleic acid) which does not contain preservatives (parabens) or known allergens. | Device: Laboratoires Mercurochrome Reparador<br>* Developed for the treatment of damaged or fragile skin.<br>* Other names: Urgo Repair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin acceptability through the self perception of patients. | Measure the skin acceptability through the self perception of patients with the daily use of the product adding in a questionnaire the product effectiveness. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Instrumental Performance Measures | Instrumental measurements will be carried out through the Skin-Thermometer ST equipment 500 - Courage + Khazaka in the feet of participants with the aid of a dermatologist. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Skin acceptability, Clinical Research