Bruxism
Conditions
Interventions
This is a double-blind randomized clinical study. Experimental group: 22 participants, including men and women aged between 20 and 50 years old, who will undergo thermogram capture using a thermograph
D04.615.638.400.900
Sponsors
Universidade Federal do Rio de Janeiro
Faculdade de Ciências Farmacêuticas da Universidade Estadual de Campinas
Eligibility
Age
2 Years to 60 Years
Inclusion criteria
Inclusion criteria: Age between 2 and 60 years; Atopic Dermatitis diagnosis according to the Hanifin and Rajka criteria, confirmed by reviewing the medical record; patients under follow-up at the dermatology outpatient of the referred hospital for at least 6 months; presence of active lesions in the upper limbs; not using topical corticosteroids of any potency at the product application site 30 days before the start of the study; atopic dermatitis severity assessed by a physician through the measurement of the Eczema Activity Severity Index (EASI) greater than 7; atopic dermatitis severity assessed by a physician using the Atopic Dermatitis Antecubital Severity score (ADAS); both genders
Exclusion criteria
Exclusion criteria: Presence of any other dermatosis in the product application area; history of hypersensitivity to simvastatin oral administration or any other statin; unstable skin condition defined by at least one of the following criteria in the last 3 months: change of systemic medication, antibiotics uses, hospitalization due to atopic dermatitis; oral antihistamines will be allowed as long as they are maintained at the dose prior to the start of the study; change in topical treatment in the month prior to the start of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total bacterial quantification of Staphylococcus aureus. Verified by the culture quantification method and total quantification, using the real-time polymerase chain reaction (RT-PCR) method. It is expected to find a reduction of at least 1 log of CFU/ML.;To evaluate the improvement in the severity of the lesion using the indexes: Eczema Activity Index (EASI), Atopic Dermatitis Antecubital Severity (ADAS) and Scoring Atopic Dermatitis (SCORAD). It is expected to find a reduction of at least 5% in index values. | — |
Secondary
| Measure | Time frame |
|---|---|
| Intensity of itching in the region of the lesion, assessed using the visual analogue scale. A reduction of at least 5% in the level of itching is expected.;Patient satisfaction, assessed through a questionnaire with sensory perception scales and improvement in skin aspects. Expect improvement in patient satisfaction.;Skin hydration, assessed using the corneometer. An improvement in the patients' skin hydration level is expected, greater than or equal to that found at baseline. | — |
Countries
Brazil
Contacts
Public ContactSindy Roque
Faculdade de Ciências Farmacêuticas da Universidade Estadual de Campinas
Outcome results
None listed