A Randomized, Double Blind and Placebo-Controlled Clinical Trial to Evaluate the Effect of a Probiotic in Patients With Acne
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 7
- 主要终点
- Change from baseline in the AGSS (Acne Global Severity Scale) index at 12 weeks
研究概览
简要总结
A 12-week randomized, multicenter and double-blind, placebo-controlled study to evaluate the effect of a probiotic in the clinical and subjective evolution of acne in adolescent and adult patients.
详细描述
Acne is a chronic inflammatory disease of the skin that affects 85% of younger adults in westernized populations. Acne pathophysiology is multifactorial and may include alterations of the pilosebaceous unit function, skin microbiota, hormone imbalance and gut microbiota. Acne pathology shares features with inflammatory chronic conditions such as metabolic syndrome, obesity or diabetes.
Probiotics are live microorganisms that when administered in adequate amounts confer a health benefit for the host. Probiotics are proposed for the treatment of inflammatory chronic conditions, including dermatological diseases as atopic dermatitis and psoriasis. However, the clinical evidence is limited. Therefore, usefulness of probiotics for acne vulgaris treatment must be ascertained in humans.
This randomized study aims to evaluate the effect of a probiotic on the treatment and clinical and subjective evolution of acne vulgaris.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signature of informed consent by the patient (and their legal guardian in case of being under age).
- •Age between 12 and 30 years-old.
- •AGSS (Acne Global Severity Scale) Score: 2 or higher
- •Patients who agree to follow the study's dietary recommendations.
排除标准
- •Contraindication of any of the components of the product under study.
- •Topical or systemic use of antifungals and antibiotics in the previous 2 weeks.
- •Consumption of probiotics in the previous 2 months.
- •Use of systemic retinoids in the previous 6 months.
结局指标
主要结局
Change from baseline in the AGSS (Acne Global Severity Scale) index at 12 weeks
时间窗: 0 and 12-week
Score between 0 and 5: 0: Clean = Normal and clear skin without evidence of acne 1. Almost clean = There are some non-inflammatory lesions, with uncommon and non-inflamed papules 2. Mild = few inflammatory lesions (no nodule-cystic lesions) 3. Moderate = Noninflammatory lesions predominate, but multiple inflammatory lesions appear (nodule-cystic lesions may be present) 4. Severe = Inflammatory lesions predominate (nodule-cystic lesions may be present) 5. Very severe = Highly inflammatory lesions predominate (several nodule-cystic lesions) Patients who improve in at least one category of the scale are considered as responders to treatment.
次要结局
- Change from baseline in the number of acne lesions at week 12(0 and 12-week)
- Change from baseline in the GAGS (Global Acne Grading System) index at week 12(0 and 12-week)
- Change in the percentage of patients with presence of Cutibacterium acnes and Staphylococcus aureus in skin microbiome(0 and 12-week)
- Use of antibiotic acne treatment(12-week)
- Change from the baseline in the patient subjective evaluation index at week 12(0 and 12-week)
- Treatment safety assessed by number of adverse events(12-week)
- Adherence to treatment(12-week)