Prospective, evaluator-blinded, randomized, three-arm, comparative, in-use tolerability, three-products, safety and efficacy study in mild to moderate acne patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of the test products in terms of
研究概览
简要总结
This is prospective, interventional, evaluator-blinded, randomized, comparative, three-arm, safety, In-Use tolerability and efficacy study in mild to moderate acne patients. . Total of 96 subjects (32 subjects/test product) will be enrolled to complete 90 (30 subjects/test product) complete the study.
Total 3 visits were included.
Visit 01 (Day 01): Screening and Enrolment, Baseline Evaluations
Visit 02 (Day 07 ±2 days): Test Product Usage Period, Evaluations
Visit 03 (Day 28 ±2 days): Evaluations, End of Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 16 to 35 years (both inclusive) old at the time of consent.
- •(Preferably equal number of males and females will be enrolled in the study) 3) Females of childbearing potential have a self-reported negative urine pregnancy test at the time of the screening visit and agree to follow an accepted method of birth control for the duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device etc.
- •Patients are generally in good general health as determined from recent medical history.
- •Patients with acne of mild to moderate severity as per the IGA scale.
- •Patients who commit not to use medicated skincare products (OTC products, cosmeticcomedogenic products, moisturizing products, anti-acne and anti-seborrhoeic products) other than the test product for the entire duration of the study.
- •Patients is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
- •If the Patients is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence).
- •Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
- •Patients are willing to give written informed consent and are willing to come for regular follow up.
- •Willing to use test product throughout the study period.
排除标准
- •History of any dermatological condition of the skin disease.
- •Subject with present condition of allergic response to any cosmetic product.
- •Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, antihistamines, corticosteroid therapy etc.) that might influence the outcome of the study.
- •Subject having acne of severe incidence (presence of nodules, cysts) which requires pharmaceutical product.
- •Subjects had performed any acne treatment throughout the study.
- •Subjects who have applied topical product for at least 4 weeks and any systemic product for at least 3 months, adjuvant product/therapy before they participated in the study.
- •History of alcohol or drug addiction 8) Subjects using other marketed anti-acne products during the study period.
- •Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
- •Pregnant or breastfeeding or planning to become pregnant during the study period.
- •History of chronic illness which may influence the cutaneous state.
- •Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.
结局指标
主要结局
To evaluate the effectiveness of the test products in terms of
时间窗: Before usage of the test products on Day 01 and after usage of test products at T20 mins on Day 01, Day 07, Day 28
1. change in sebum level.
时间窗: Before usage of the test products on Day 01 and after usage of test products at T20 mins on Day 01, Day 07, Day 28
2. change in acne severity by investigator global assessment scale. (IGA Scale)
时间窗: Before usage of the test products on Day 01 and after usage of test products at T20 mins on Day 01, Day 07, Day 28
次要结局
- To evaluate the effectiveness of the test products in terms of(1. change in total acne lesions.)
研究者
Dr Nayan Patel
NovoBliss Research Private Limited