Healthy Volunteers
Conditions
Interventions
The participants of the present study will be submitted to an evaluation of the effect of digital applications on the behavior of individuals in relation to sun exposure during leisure time on the Bra
- Clinical evaluation of the inclusion and non-inclusion criteria
- Guidelines for returning on the day and time scheduled for the blood test (vitamin D) and installation of the application, according to randomization, being:
Group I: 20 participants who will use th
-Clinical assessment of the participant regarding his history of sun exposure, weight and height to calculate BMI and body area
- Blood test in the laboratory to evaluate vitamin D
Visit 03 (D1) / Visit 04 (D2) / Visit 05 (D3)
- Measurements of intensity of erythema on the skin using the Mexameter® equipment, on the face (forehead), arms and buttocks region (area without sun exp
- Directing the participants to the beach to start the study, where they will follow the guidelines of the application according to their study group, with sun exposure will be carried out from 9 am t
Device
L01.224.900.685
Sponsors
Medcin Instituto da Pele Ltda
Medcin Instituto da Pele Ltda
Eligibility
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Aged 18 to 50; Phototypes I to III, as per Fitzpatrick classification (Population makeup: Phototype I = 20%; Phototype II= 40%; Phototype III= 40%); Intact facial and body skin; Not taking restrictive diet (or having completed diet at least 6 months before assessment); Have a smartphone (iOS or Android) - minimum requirement iOS 9.0 (or later) or Android 5.0 (or later); In the investigator’s opinion, they are able and willing to comply with all study requirements; Understand, agree and sign the Informed Consent Form.
Exclusion criteria
Exclusion criteria: Pregnancy/breastfeeding or intention to become pregnant; Use of the following topical or systemic drugs: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs, and corticosteroids up to 30 days prior to screening or, in the case of immunosuppressants, the interval must be 3 months prior to screening; Use of vitamin D supplements up to 03 months prior to assessment; Planned elective surgery or other procedures that require hospitalization and/or general anesthesia during the study; Use of topical or systemic photosensitizing medication up to 01 month prior to screening; History of phototoxic or photoallergic reactions; Photoinduced pathologies, such as solar urticaria, lupus erythematosus, polymorphic light eruption, simple recidivating herpes; Vitiligo; Atopical or allergic histories to cosmetics; Pathologies and/or active skin lesions (local and/or spread) on the assessment site; Skin marks on the experimental site that interfere with the assessment of possible skin reactions (vascular malformations, scars, increased pilosity, big amount of nevus, sunburns); Immunosuppression by drugs or active diseases; Subjects bearers of known congenital or acquired immunodeficiency; Relevant clinical history or current evidence of abuse of alcohol or other drugs; Known history or suspected intolerance to sunscreens; Moderate/intense solar exposure up to 03 months prior to assessment; Aesthetic or dermatological treatment on the assessment site up to 04 months prior to screening; Other conditions considered by the assessing physician as reasonable to disqualify the clinical study subject. If so, it must be written under observation in the clinical record.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the effect of a digital application integrated to a wearable device, regarding solar exposure behavior of individuals while they enjoy their time on the Brazilian coast, by monitoring the synthesis of vitamin D after exposure and instrumental assessment of intensity of the erythema produced. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess whether recommendations provided by the application on the amount of sunblock to be used have positive impact on photoprotection. Compare the effect of three digital applications, being one of them integrated to a wearable device, regarding solar exposure behavior of individuals while they enjoy their time on the Brazilian coast, by monitoring the synthesis of vitamin D and the intensity of the erythema produced | — |
Countries
Brazil
Contacts
Public ContactDr. Sérgio Schalka
Medcin Instituto da Pele Ltda
Outcome results
None listed