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临床试验/CTRI/2022/05/042503
CTRI/2022/05/042503已完成未知

To evaluate the safety and efficacy of a skin care formulation in terms of reduction in appearance of wrinkles & fine lines & visible improvement in skin firmness, skin moisturization, skin plumpness & skin smoothness on healthy female subjects

Transformative Learning Solution Pvt Ltd0 个研究点目标入组 33 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
33

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 Female subjects
  • 2)Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup)
  • 3)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar)
  • 4)Having crows feet wrinkles, fine lines & visibly loose skin

排除标准

  • 1Female subjects who are pregnant (determined by Urine pregnancy test) or breastfeeding or having stopped to breastfeed in the past three months
  • 2Having refused to give her assent by not signing the consent form
  • 3Taking part in another study liable to interfere with this study
  • 4Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
  • 5Having a progressive asthma (either under treatment or last fit in the last 2 years)
  • 6Being epileptic.
  • 7Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
  • 8Having cutaneous hypersensitivity
  • 9Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
  • 10Having known allergy to any of the Ingredient of the Test Product
  • 11Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
  • 12Having consumed caffeine-based products (coffee, cola, tea â?¦), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements
  • 13Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
  • 14Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit
  • 15Having applied a cosmetic product (included make-up) or skin care product on the studied areas on the day of the study (only face cleaned with water is accepted)
  • 16Refusing to follow the restrictions below during the study:Do not take part in any family planning activities leading to pregnancy and breastfeeding, Do not take part in another study liable to interfere with this study, Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol), Do not consume any caffeine-based products (coffee, cola, tea â?¦), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements, Do not change her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit, During the study: Do not use other cosmetic products or skin care products other than the tested products to the studied areas. (only usual cleanser/soap is accepted), The day of the measurements : No test product must be used (only test site cleaned with water is accepted)
  • 17Having started, changed or stopped a Hormone Replacement Therapy in the past 6 months.
  • 18Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months.
  • 19Having taken a Dehydroepiandrosterone based treatment in the previous 6 months.
  • 20Having applied products with an anti-wrinkle action particularly firming products (Retinoic acid, retinol, retinaldehyde, Alpha Hydroxy Acidâ?¦.) in the 2 weeks preceding the start of the study.
  • 21Having made injections of anti-wrinkle products (collagen, hyaluronic acid, botulinic toxinâ?¦) in the previous 12 months.
  • 22Having undergone techniques with aesthetic aim (chemical peel, mechanical dermabrasion, laser, pul

研究者

发起方
Transformative Learning Solution Pvt Ltd

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