Clinical trial NCT02695706: Clinical Study, Opened, of Cutaneous Acceptability of a Topic Product in Normal Conditions of Use
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Diabetes
Keywords: Diabetes
Skin acceptability
Clinical Research
Lead sponsor: LM Farma Indústria e Comércio Ltda.
Sponsor class: INDUSTRY
First posted: 2016-03-01
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Skin acceptability through the self perception of patients.
timeFrame: 2 months
Secondary outcomes:
measure: Instrumental Performance Measures
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Urgo
name: Alexandre Tepas, Graduated
role: STUDY_DIRECTOR
References: