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临床试验/CTRI/2012/07/002771
CTRI/2012/07/002771已完成2 期

A Phase II, randomized, double blind, placebo controlled, monocentric study to evaluate the efficacy and safety of Anti Ageing and Regeneration Cream in Healthy Human Volunteers

Sami Labs0 个研究点目标入组 30 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
30

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

  • Subjects in generally good health
  • Subjects of skin types III, IV, and V.
  • Subjects age group 30 - 55 years
  • Subjects willing to give a written informed consent and come for a regular follow up.
  • Subject willing to abide by and comply with the study protocol
  • Subject has not participated in a similar investigation in the past four weeks.
  • Subjects having visible fine lines and wrinkles in periorbital area (Crowâ??s feet),nasolabial areas, forehead ,and perioral regions of the face
  • Subjects having mild to moderate nasolabial folds
  • Subjects having apparent mild to moderate crowâ??s feet in unanimated face
  • Subjects who have not under gone any facial anti ageing procedures (e.g. Botulinum toxin, dermal filler injections, laser resurfacing) in the past 3 months.
  • Subject should be willing to abstain from spa treatments/facials during the study period

排除标准

  • A known history or present condition of allergic response to any cosmetic products.
  • Subjects having severe photoaging.
  • Subject having skin diseases (e.g. moderate to severe acne vulgaris face or nodulocystic acne, psoriasis, active atopic dermatitis, melasma, lichen planus pigmentosus/ Achy dermatosis, pigmented contact dermatitis or other cutaneous manifestations), which will interfere with the test readings.
  • Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study.
  • Systemic treatment which may modify the cutaneous state on the day of inclusion or in the previous 30 days, including retinoid therapy.
  • Subjects not willing to discontinue other topical anti ageing, anti wrinkle facial products.
  • Subjects who are pregnant, lactating or nursing.
  • Hypersensitivity to any component of the tested products.
  • History of intense sun exposure.
  • Chronic illness which may influence the cutaneous state.
  • Subject participating in any other cosmetic or therapeutic trial.
  • Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness.

研究者

发起方
Sami Labs

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