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临床试验/CTRI/2019/09/021246
CTRI/2019/09/021246尚未招募3 期

A randomized, double-blind, placebo controlled, monocentric study to evaluate the Anti Ageing efficacy and safety of Olepent® cream in Healthy female subjects.

Sami Labs Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方

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 Female adult subjects in general good health as determined from a recent medical history general physical examination, dermatological assessment.
  • 2 Subjects in the age group of 35-50 years (both ages inclusive).
  • 3 Subject with Fitzpatrick skin types III to V.
  • 4 Subjects having visible fine lines and wrinkles in periorbital area (Crows feet under eye) and forehead
  • 5 Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.
  • 6 Subject who agrees not to use any other product/treatment/home remedy except the provided dove soap bar on their face during the study period other than the test product.
  • 7 Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period.
  • 8 Subjects who agree not to expose to excessive sun light. (Sun exposure not more than half an hour daily and during that time use of umbrella to cover face).
  • 9 Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow up.
  • 10 Subjects willing to abide by and comply with the study protocol.

排除标准

  • 1 Subject with any other signs of significant local irritation or skin disease.
  • 2 Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data.
  • 3 Subject having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year.
  • 4 Subjects who do not agree to remove all jewellery on/around face (e.g. necklace,earrings,if possible nose ring),during VISIA imaging.
  • 5 Subjects having hairstyle which covers almost the entire forehead.
  • 6 Subjects undergoing any treatment of any skin condition on their face/forearm.
  • 7 Subjects not willing to discontinue other topical facial products.
  • 8 Subject allergic or sensitive to bar cleansing products, cosmetics, creams/lotions, artificial jewellery or anything else.
  • 9 Pregnant women (as confirmed by UPT) and lactating women.
  • 10 Subjects on any medical treatment either systemic/topical in the past 1 month or currently taking medication including food supplements.
  • 11 Subjects with skin allergy history or atopic dermatitis or psoriasis
  • 12 Subjects who have participated in any other clinical trial in the last 3 months.
  • 13 Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study
  • 14 Subjects that was treated with botox/filler /biostimulatory molecules injection.

研究者

发起方
Sami Labs Limited

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