Clinical Study, Opened, of Cutaneous Acceptability of a Topic Product in Normal Conditions of Use
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|ClinicalTrials.gov Identifier: NCT02695706|
Recruitment Status : Unknown
Verified February 2016 by LM Farma Indústria e Comércio Ltda..
Recruitment status was: Not yet recruiting
First Posted : March 1, 2016
Last Update Posted : March 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Device: Laboratoires Mercurochrome Reparador||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||July 2016|
Experimental: Laboratoires Mercurochrome Reparador
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
Developed for the treatment of damaged or fragile skin.
Other Name: Urgo Repair
- Skin acceptability through the self perception of patients. [ Time Frame: 2 months ]Measure the skin acceptability through the self perception of patients with the daily use of the product adding in a questionnaire the product effectiveness.
- Instrumental Performance Measures [ Time Frame: 2 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02695706
|Contact: Nesser C Oliveira, Graduatedfirstname.lastname@example.org|
|Contact: Sheila M Vieira, Graduatedemail@example.com|
|Study Director:||Alexandre Tepas, Graduated||Urgo|