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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
Sponsor:
Information provided by (Responsible Party):
LM Farma Indústria e Comércio Ltda.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Device: Laboratoires Mercurochrome Reparador Early Phase 1

Detailed Description:

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.


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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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Nesser C Oliveira, Graduated 551230021316 n.oliveira@br.urgo.com
Contact: Sheila M Vieira, Graduated 551232021316 s.vieira@br.urgo.com

Sponsors and Collaborators
LM Farma Indústria e Comércio Ltda.
Investigators
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Study Director: Alexandre Tepas, Graduated Urgo

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Responsible Party: LM Farma Indústria e Comércio Ltda.
ClinicalTrials.gov Identifier: NCT02695706     History of Changes
Other Study ID Numbers: LM Farma
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by LM Farma Indústria e Comércio Ltda.:
Diabetes
Skin acceptability
Clinical Research