A Single Centric, Open Label, Non Randomized Phase IV Post Marketing Surveillance Study to Measurethe Efficacy and Safety of Roop Mantra Cucumber Ayurvedic Medicinal Face Wash on Subjects Sufferingfrom Acne, Face Scars, Pimples, Blemishes, Dull& Dry skin.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1. Assessment of Skin Recovery (Change from Baseline) over a period of 30 Days in the subjects who have undergone in topical application of Roop Mantra Cucumber Ayurvedic Medicinal Face wash.
研究概览
简要总结
TheStudy has been designed to evaluate the efficacy of Roop Mantra Cucumber Ayurvedic Medicinal Face washin adult human subject in order to check the Safety and evaluate the benefitsof product Roop MantraCucumber Ayurvedic Medicinal Face wash as per dermatologicalparameters.
TheStudy is an open label, single armed, single centric, Non-randomized, Phase IVPost marketing surveillance study on 120 subjects.
There are three visits in the study. On screeningvisit i.e., day 1, the subjects will be screened based on inclusion andexclusion criteria. Eligible subjects will be enrolled into the study afterinformed consent procedure. Eligible Subjects will be provided with the informedconsent document and will be briefed about all study related procedure indetail. The site Investigator will explain the subject about all study relatedprocess and the visit 2 – Day 15 and Visit 3 Day 30(Final Visit). All eligiblesubjects will then be provided with Test Product – Roop Mantra Cucumber Ayurvedic Medicinal Face wash byInvestigator/study coordinator. In the presence of Investigator, theinstructions will be given to use the test product at home from Day 1 to Day 30i.e., Take small quantity in your palm and mix it with little water twice daily, preferably morning andevening.Massage gently over face & neck in circular motion. Rinse thoroughly withwater.
A dermatological evaluation /assessment shall beperformed on baseline Day 0 and final visit- Day 30. A self- assessmentquestionnaire shall be given to all eligible subjects on Baseline and finalvisit. This is an open label, non-randomized study involving healthy volunteersbetween age 18-45 years.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Age Between 18-45 Years
- •Male and Female subjects with general physical good mental condition
- •Willingness to take part in study and able to attend all scheduled visits
- •Skin type with acne, facial scars, pimples, blemishes, dull & dry skin.
排除标准
- •Pregnant , Breastfeeding , subjects undergone any surgery and else take taken part in any cosmetic clinical trial
- •Not willing to sign the ICF or give the consent
- •Mole, Tattoos or any kind of allergy on the skin due to external or internal factor
- •Any Kind of psoriasis, leucoderma disorder and skin surgery
- •Use of facial bleach, facial scrub, hair removal or any other product within 2 weeks prior to screening.
结局指标
主要结局
1. Assessment of Skin Recovery (Change from Baseline) over a period of 30 Days in the subjects who have undergone in topical application of Roop Mantra Cucumber Ayurvedic Medicinal Face wash.
时间窗: 1. Assessment of Skin Recovery (Change from Baseline) over a period of 30 Days in the subjects who have undergone in topical application of Roop Mantra Cucumber Ayurvedic Medicinal Face wash. | 2. Assessment of Skin Recovery and removal of scars from baseline over a period of 30 days
2. Assessment of Skin Recovery and removal of scars from baseline over a period of 30 days
时间窗: 1. Assessment of Skin Recovery (Change from Baseline) over a period of 30 Days in the subjects who have undergone in topical application of Roop Mantra Cucumber Ayurvedic Medicinal Face wash. | 2. Assessment of Skin Recovery and removal of scars from baseline over a period of 30 days
次要结局
- Self assessment questionnaire filled by subject shall be taken from baseline to final visit to show the change in skin type designed on any parameter(At the end of 15 days and at th end of 30 days)