RBR-2mf6qg已完成未知
EN19-0771-01- Clinical study aiming to monitor the use of mobile applications for their potential of impacting an individual’s sun exposure behavior, by assessing vitamin D synthesis and production of erythema after sun exposure - NA: NA
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18Y 至 50Y(—)
入选标准
- •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.
排除标准
- •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.
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