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

NCT02695706 | Unknown Early Phase 1 DMC

• 1 other identifier: LM Farma
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes

Keywords

Diabetes; Skin acceptability; Clinical Research

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Instrumental Performance Measures

  2 months

Study Arms (1)

Laboratoires Mercurochrome Reparador

EXPERIMENTAL

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

Interventions

Laboratoires Mercurochrome Reparador DEVICE

Developed for the treatment of damaged or fragile skin.

Also known as: Urgo Repair

Laboratoires Mercurochrome Reparador

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• LM Farma Indústria e Comércio Ltda.: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Alexandre Tepas, Graduated

  Urgo

  STUDY DIRECTOR

Central Study Contacts

Nesser C Oliveira, Graduated

CONTACT

551230021316; n.oliveira@br.urgo.com

Sheila M Vieira, Graduated

CONTACT

551232021316; s.vieira@br.urgo.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: March 1, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 3, 2016

Record last verified: 2016-02