Monitoring the use of cellular applications for the influence on the behavior of individuals during sun exposure

Not Applicable

• Conditions: Healthy Volunteers; M01.774.500

• Registration Number: RBR-2mf6qg
• Lead Sponsor: Medcin Instituto da Pele Ltda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-09
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified