Estudio clínico Para Evaluar Los Efectos y la Seguridad de un Producto cosmético en Sujetos Con Signos de Envejecimiento cutáneo.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Wrinkle Reduction
研究概览
简要总结
This clinical study investigates the effects and safety of a topical cosmetic product containing postbiotics (Bifida ferment extract and Pediococcus ferment extract) in women aged 35-60 with visible signs of skin aging.
The study is a 3-month, single-center, intra-subject controlled trial involving 45 Caucasian women with sensitive or normal skin. Participants will apply 1 ml of the product twice daily. Clinical evaluations will be conducted at baseline and at 1 month, 2 months, and 3 months, using validated dermatological scales and non-invasive instruments (AEVA3D, Mexameter®, MoistureMap®, Cutometer®, Tewameter®, Clarius®, Glossymeter®).
Safety will be assessed through systematic monitoring of adverse events, with serious adverse events expected to remain below 1%. Subjective perception will be evaluated via structured questionnaires.
详细描述
This clinical study is designed to evaluate the effects and safety of a topical cosmetic product formulated with postbiotic ingredients in adult women presenting visible signs of skin aging. The product contains Bifida ferment extract and Pediococcus ferment extract, selected for their scientifically supported properties in enhancing skin barrier function, reducing oxidative stress, and improving overall skin appearance.
The study is a prospective, single-center, intra-subject controlled clinical trial with a total duration of three months. Forty-five Caucasian women aged between 35 and 60 years will be enrolled. Participants must present mild to moderate facial wrinkles and/or pigmentation spots and will be evenly distributed between sensitive and normal skin types. Inclusion and exclusion criteria are clearly defined to ensure participant safety and data reliability.
Participants will apply 1 ml of the cosmetic product twice daily (morning and evening) to clean, dry facial skin. The study includes four scheduled visits: pre-selection, baseline (T0), (T1), 1 month (T2), 2 months (T3), and 3 months (T4). During these visits, clinical assessments will be conducted using validated dermatological scales (Skin Aging Atlas and Glogau scale) and non-invasive instrumental evaluations.
Instrumental assessments include AEVA3D, Mexameter®, MoistureMap®, Cutometer®, Tewameter®, Clarius®, Glossymeter®.
Photographic documentation will be performed using Visiofaceae, capturing standardized facial images at each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female participants.
- •Age between 35 and 60 years.
- •All skin types (combination, oily, dry, and/or normal).
- •Skin condition: 50% sensitive skin and 50% normal skin.
- •Visible signs of facial skin aging (mild/moderate wrinkles and/or pigmentation spots).
- •Willingness to participate voluntarily and provide written informed consent.
- •Ability to understand the study objectives and procedures.
- •Good general health (physical and mental).
- •Availability to attend all scheduled visits at the research center.
- •Discontinuation of anti-aging products on the experimental area (face) at least 7 days prior to study start.
- •Commitment not to change facial hygiene routines during the study.
排除标准
- •Pregnant or breastfeeding women.
- •History of allergy to cosmetic products and/or dietary supplements.
- •Known allergy or hypersensitivity to any component of the product.
- •History or current diagnosis of cancer.
- •Active skin diseases or infections in the experimental area.
- •Recent or planned surgical or aesthetic interventions in the experimental area Medical-aesthetic treatments on the face within the last 6 months (e.g., botulinum toxin, hyaluronic acid, laser, radiofrequency, HIFU, deep chemical peels, microneedling with actives).
- •Relevant dermatological conditions in the experimental area (eczema, psoriasis, allergic/contact dermatitis, etc.).
- •Use of topical or systemic medications affecting the skin (retinoids, antibiotics, corticosteroids) within the last 3 months.
- •Current or planned use of supplements that may affect skin health (collagen, antioxidant vitamins A/C/E, zinc, omega-3, oral probiotics/prebiotics).
- •Systemic diseases such as autoimmune disorders (rheumatoid arthritis, lupus, multiple sclerosis), chronic viral infections (HIV, hepatitis B/C), or severe metabolic diseases.
- •Use of any product other than the study product on the experimental area during the study.
- •Planned significant changes in health habits during the study (diet, physical activity, structured exercise programs).
- •Recent or planned changes in hormonal contraceptives.
- •Sun or UVA exposure during the study.
- •Participation in another clinical study involving the same experimental area
- •Application of any product on the experimental area on the day of study initiation.
- •Any medical condition, at the investigator's discretion, that may interfere with protocol adherence or participant safety.
研究组 & 干预措施
Study Arm
Open Label Active Product
干预措施: Active cream (Other)
结局指标
主要结局
Wrinkle Reduction
时间窗: From baseline to the end of treatment at 3 months
Changes in visible signs of skin aging (wrinkles and spots) after 3 months of continuous application. Assess the evolution of wrinkles using AEVA3D-HE2.
次要结局
- Spot Depigmentation(From baseline until the end of treatment at 3 months)
- Facial Contour Evolution(From baseline until the end of treatment at 3 months)
- Spot Evolution(From baseline until the end of treatment at 3 months)
- Skin Hydration(From baseline until the end of treatment at 3 months)
- Firmness & Elasticity(From baseline until the end of treatment at 3 months)
- Barrier Function(From baseline until the end of treatment at 3 months)
- Dermal Thickness(From baseline until the end of treatment at 3 months)
- Skin Radiance(From baseline until the end of treatment at 3 months)
- Self-perceived improvement(From baseline until the end of treatment at 3 months)