CTRI/2021/07/034984已完成2 期
Efficacy, Safety and Sensory Evaluation of Serum in Conferring Acne Reduction in Healthy Human Volunteers with acne prone and Sensitive Skin Type - None
ITC Life Sciences Technology Centre0 个研究点目标入组 45 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Indian/Asian female subjects
- •2.Healthy subjects between 18 and 35 years of age.
- •3.Skin in healthy on the studied anatomic site (free of eczema, wounds, cuts, bruises, inflammatory scar)
- •4.Subjects willing to abide by the study protocol and restriction (refrain from using any product other than provided investigational product (IP)).
- •5.Subjects with sensitive skin fairly in equal representation of varied skin types i.e. Dry, Normal, Oily & Combination Skin type in equal ratio.
- •6.Subjects who score greater than 30 for section 2- sensitive vs resistant skin in Dr. Baumannââ?¬•s questionnaire.
- •7.22 subjects with sensitive skin type with acne of mild severity as per global acne grading scale.
- •8.23 subjects with sensitive skin type with acne of moderate severity as per global acne grading scale.
- •9.Subjects who tolerate the IP well showing no sensitivity symptoms during sensitivity test.
- •10.Subjects who are willing to use the face serum and cleanser provided (and no other leave on moisturizer/serum) during the study duration.
- •11.Subjects will to visit the study centre for periodic assessment on the scheduled dates.
- •12.Subjects who have not participated in a similar investigation in the past eight weeks.
排除标准
- •1.Subjects who are pregnant or nursing (as confirmed by Urine pregnancy test for the determination of Pregnancy).
- •2.Subjects with a present condition of allergic response to any cosmetic product.
- •3.Subjects undergoing treatment for anti-acne or skin lightening.
- •4.Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines etc.) that might influence the outcome of the study.
- •5.Subjects who has used any systemic medication (antibiotics, oral contraceptive pills, steroids, or any other anti-acne medication) or any topical facial medication with in past 4 weeks.
- •6.Having acne of severe incidence (presence of Nodules, Cysts or numerous pustules) which requires pharmaceutical treatment.
- •7.Subjects with excessive facial hair or scars, which could interfere with evaluation.
- •8.Subjects having cutaneous hypersensitivity.
- •9.Subjects participating in any other cosmetic or therapeutic trial.
- •10.Subjects having changed her cosmetic habits required as per protocol before the start of the study on the studied site.
研究者
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