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

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes
• Intervention / Treatment: Device: Laboratoires Mercurochrome Reparador

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.

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Nesser C Oliveira, Graduated; Phone Number: 551230021316; Email: n.oliveira@br.urgo.com
• Study Contact Backup: Name: Sheila M Vieira, Graduated; Phone Number: 551232021316; Email: s.vieira@br.urgo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Urgo Repair

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: LM Farma Indústria e Comércio Ltda.
• Investigators: Study Director: Alexandre Tepas, Graduated, URGO

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: February 12, 2016
• First Submitted That Met QC Criteria: February 29, 2016
• First Posted (Estimate): March 1, 2016

Study Record Updates

• Last Update Posted (Estimate): March 3, 2016
• Last Update Submitted That Met QC Criteria: March 1, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Diabetes; Clinical Research; Skin acceptability
• Other Study ID Numbers: LM Farma

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided