A randomized, single blind, parallel group, controlled clinical study to evaluate the efficacy of investigational product versus 0.1% adapelene in patients with acne vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- All the changes will be assessed compared to the baselines values with respect to reduction in number and severity of inflammatory/non inflammatory lesions.
研究概览
简要总结
Acne is a chronic disease of sebaceous follicles that is multifactorial in etiology. It can wax and wane in severity according to lesion types, numbers, and extent of involvement and can result in scarring. Acne occurs more frequently on the face, but can also occur on the non-facial skin (e.g., trunk). There are two major types of acne lesions:
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Non-inflammatory: Non-inflammatory lesions are the open (blackheads) or closed (whiteheads) comedones.
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Inflammatory: Inflammatory lesions include papules, pustules, and nodules.
Although most drug products for acne are intended for the broad indication of acne vulgaris, some drug products have been developed that only target one of these two lesion subsets. Acne is primarily a disease of adolescence and young adulthood but can persist past the third decade of life.
Numerous topical and systemic drugs have been developed in the past years and most, if not all, are available in India. The challenge is to meet the rising expectations of the youth of India, who make up the bulk of acne population and will demand the best. For successful treatment of acne, new formulations in combination therapy have been developed. These formulations will not only increase the efficacy of the treatment but also boost the adherence. Furthermore, they minimize the resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 11.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group 11 yrs.
- •and 30 yrs.
- •Both genders
- •Patients with inflammatory and non-inflammatory papules, open and closed comedones with few pustules present over the skin.
- •AGSS score more than 1
- •Count lesion of more than 10
- •Lesion to be present for not less than 3 months (recurrent lesions are included)
- •Able to give informed consent.
- •For patients younger than 18 years old, representatives (parents/guardians) are required to provide informed consent and the same will be documented.
排除标准
- •Subjects on any other medication or cosmetics
- •Subjects using other anti-acne medications in the last 30 days before study
- •Patients with history of allergy to topical antibiotics
- •Pregnant women, those who may be pregnant, lactating women, and women who hope to become pregnant during the study period
- •Patients who had participated in other clinical studies within 3 months of the start of the study
- •Subjects who have any clinically significant allergic disease at the time of first examination or unwilling to enter into the study because of recent drug allergy.
- •History or presence of any debilitating disease like cancer, RA, TB etc.
- •Patients on OCP, antibiotics.
- •Patients with cystic acne and acne rosacea.
- •Patients on MAOI, ant- epileptics treatment, lithium.
- •PCOD / Underlying endocrine disease.
- •Patients with nodulocystic acne and acne fulminans.
- •Patients on steroids and ATT.
结局指标
主要结局
All the changes will be assessed compared to the baselines values with respect to reduction in number and severity of inflammatory/non inflammatory lesions.
时间窗: Day 0, Day 7 and Day 15
次要结局
未报告次要终点