Clinical Evaluation and Study of the Efficacy of a Centella Asiatica-Infused Facial Mask on Discosmetic Dermatosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical erythema Score (CEA)
研究概览
简要总结
The purpose of this study was to investigate the efficacy and safety of repairing facial mask containing Asiaticum asiatica in treating disjunctive skin diseases. A multi-center randomized double-blind self-half face control method was used. A computer-generated randomization method was used. Each cheek was randomly assigned to receive the snow glycoside mask and the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet mild to moderate rosacea, acne diagnostic criteria; Meet the diagnostic criteria for melasma;
- •Over 18 years of age;
- •Be able to follow the treatment rules of the study and be followed for 8 weeks;
- •Informed consent; 5There were no significant cardiac, liver, kidney, gastrointestinal, neurological, psychiatric, or metabolic disorders
- •6.No medication was used within 1 month
排除标准
- •Currently pregnant, planning to become pregnant or breastfeeding;
- •Documented hypersensitivity to any active ingredient or excipient included in the study drug, or a history of adverse reactions to cosmetic products;
- •Participate in other clinical studies within 3 months before the start of the study;
- •Frequent use of Chinese medicine, sleeping pills, sedatives, anti-anxiety drugs or potentially addictive substances;
- •Present with concomitant skin conditions that may confuse the clinical assessment of rosacea, melasma, seborrheic dermatitis or pose a risk to participants, or have a history of severe skin conditions;
- •Normal use of relevant treatment (including intense pulsed light, pulsed fuel laser, oral and topical tranexamic acid, oral tetracycline antibiotics, oral compound glycyrrhizin and other anti-inflammatory drugs)
- •Patients with incomplete observation data, incomplete course of treatment and inability to take drugs as prescribed by doctors were removed
结局指标
主要结局
Clinical erythema Score (CEA)
时间窗: Patients were followed up on the day of treatment and at 1, 2, 3, 4, 6, and 8 weeks after treatment.
Clinical erythema score (CEA) was divided into no, mild, moderate and severe according to the severity of rosacea, corresponding to 0,1,2,3, respectively.
Global Aesthetic Improvement Scale Score (GAIS)
时间窗: Patients were followed up on the day of treatment and at 1, 2, 3, 4, 6, and 8 weeks after treatment.
The Global Aesthetic Improvement Scale (GAIS) score was evaluated by the treating physician and divided into four levels: very improved corresponding, substantial improvement, improvement, no change; Corresponding to the best beauty effect, significant improvement but not the best, significant improvement, no change;
Melasma Area and Severity Rating (MASI)
时间窗: Patients were followed up on the day of treatment and at 1, 2, 3, 4, 6, and 8 weeks after treatment.
The melasma Area and Severity Rating (MASI) is used to evaluate the severity of melasma. Melanin deposition was quantitatively evaluated from three aspects: area, color depth and color uniformity. Area weight: Forehead 30%, left cheek 30%, right cheek 30%, mandibular 10%, color plaque proportion (A) \< 10% recorded 1 points, 10% \~ 29% recorded 2 points, 30% \~ 49% recorded 3 points, 50% \~ 69% recorded 4 points, 70% \~ 89% recorded 5 points, 90% \~ 100% recorded 6 points; Color depth (D), color uniformity (H) scores range from 0 to 4 points, no score 0 points, slight score 1 points, moderate score 2 points, obvious score 3 points, maximum score 4 points. MASI score = forehead \[0.3A (D+H)\]+ right cheek \[0.3A (D+H)\]+ left cheek \[0.3A (D+H)\]+ mandibular \[0.1A (D+H)\], score range 0 \~ 48, score was positively correlated with melanin deposition.
次要结局
- Dermatology Quality of Life Score (DLQI)(Patients were followed up on the day of treatment and at 1, 2, 3, 4, 6, and 8 weeks after treatment.)
研究者
dai jie
Nanjing First Hospital, Nanjing Medical University.
Nanjing First Hospital, Nanjing Medical University