Evaluation of the Effectiveness and Safety of Revodiol Calming Cream® in the Management of Atopic Dermatitis Under Dermatological Control.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- SCORAD (SCORing Atopic Dermatitis) Index
研究概览
简要总结
A 56-day clinical study evaluated Revodiol Calming Cream on pediatric and adult participants with mild to moderate atopic-prone skin under dermatological supervision. The product was applied twice daily, and efficacy was assessed through dermatological scoring, instrumental measurements, and subjective questionnaires. Results aimed to show improvements in barrier function, hydration, skin texture, and reduction of erythema, dryness, and pruritus, with feedback on comfort and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sex: both.
- •Age: from 0 months onwards (includes children and adults).
- •Atopic-prone skin.
- •Mild to moderate flare-up.
- •Skin dryness.
- •Signed informed consent (by the volunteer or legal guardian as applicable).
- •Adequate understanding of the clinical study by the participant or legal guardian.
- •Good physical and psychological health.
- •No application of any product on the experimental area on the first day of the trial.
- •Availability to guarantee visits to the research center.
排除标准
- •History of allergies to cosmetic products.
- •Recent surgery or treatments in the study area.
- •Oncology patients.
- •Use of antihistamines and antibiotics within 15 days prior to the start of the study.
- •Treatment with antihistamines, antibiotics, corticosteroids, immunosuppressants or completion of such treatment within 15 days prior to the start of the study.
- •Use of any other product for dermatitis during the study.
- •Sun exposure or UVA rays during the study.
- •Participation in another clinical study.
- •Health problems that may compromise adherence to the study protocol.
结局指标
主要结局
SCORAD (SCORing Atopic Dermatitis) Index
时间窗: 56 days
The assessment with the SCORAD index included lesion extent and the intensity of objective parameters such as erythema, edema/papules, exudation/crusting, lichenification, excoriation, and dryness, as well as subjective symptoms including pruritus and sleep disturbance. The scale evaluates symptoms from 0 (no signs) to 3 (severe).
次要结局
- Biometric Analysis(56 days)
- Subjective evaluation(56 days)
- Adverse events record(28 and 56 days)
- Tolerance evaluation(56 days)