A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Clinical Trial Assessing the Effectiveness and Safety of GUGGULCERA in the Treatment of Mild to Severe Acne Vulgaris and amelioration of skin health.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Assess the Effectiveness and Safety of GUGGULCERA in the Treatment of Mild to Severe Acne Vulgaris and overall skin health
研究概览
简要总结
Acne vulgaris is a disorder of thepilosebaceous gland occurring usually at puberty but can also be seen in adultage.[1] The disease characterized by theformation of open and closed comedones (non-inflammatory lesions), papules,pustules, and nodulocystic lesions (inflammatory lesions). The diseasegenerally affects the face, arms, and back. The multifactorial pathogenesis ofacne vulgaris includes follicular hyperkeratinization, abnormal sebumproduction, bacterial proliferation, and inflammation.[2] Acnevulgaris has been divided into four grades – 1, 2, 3, and 4. Grade 1 consistsof comedones and occasional papules. Grade 2 consists of papules, comedones andfew pustules. Grade 3 consists of predominant pustules, nodules, and abscesses.Grade 4 consists of mainly cysts, abscesses, and widespread scarring.[3] The aims of treatment are to controlinflammation, decrease the activity of the sebaceous glands, normalizefollicular proliferation, and decrease bacterial colonization. Drugs used forGrades 1 and 2 (mild-to-moderate case) of acne vulgaris are topicalcomedolytics, antibacterial, and retinoids as monotherapy or combinationtherapy. Grades 3 and 4 (severe cases) of acne vulgaris require systemic antibacterialalong with topical agents.[4]
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female aged 18 – 40 years of age both inclusive in general good health Must have a definite clinical diagnosis of mild to severe acne vulgaris Grade 2 Grade 3 or Grade 4 on the Investigators Global Assessment IGA of acne severity 1 Must be willing and able to give informed consent and comply with the study procedures Female patients of childbearing potential must have been using accepted methods of birth control or must agree to continue to practice abstinence from 30 days prior to study entry to 30 days after the last administration of study drug.
排除标准
- •1.Known conditions that may interfere with the evaluation of acne vulgaris.
- •Such conditions include but are not limited to the following: rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne or folliculitis; carcinoid syndrome; squamous cell carcinoma; mastocytosis; acneiform eruptions caused by make-up or medication; bacterial folliculitis; facial psoriasis; and facial eczema.
- •2.Subjects allergic to herbal products or any component of the study product 3.Subjects who have been treated topical or oral corticosteroids within 14 days prior to baseline 4.History of uncontrolled disease or immune deficient disorder 5.Any feature in the test areas (face) that according to the investigator may influence the results, for example, but not limited to moles, tattoos, scars, irritated skin, scratches, cuts and excess hair 6.Known HIV or Hepatitis B positive or any other immuno-compromised state 7.Female subjects who are pregnant, nursing or planning to become pregnant during study participation 8.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 9.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Assess the Effectiveness and Safety of GUGGULCERA in the Treatment of Mild to Severe Acne Vulgaris and overall skin health
时间窗: Proportion of subjects in each treatment group achieving success at Week 12, with success defined as IGA score of clear or almost clear and at least a one-point reduction in IGA score compared to Baseline. | Mean percentage change in total acne, inflammatory and non-inflammatory lesion count from baseline to end of the study
次要结局
- To assess the effect of the treatment arm in comparison with placebo on the “The Cardiff acne disability indexâ€(To assess the safety and tolerability of the test product.)