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临床试验/CTRI/2013/06/003766
CTRI/2013/06/003766已完成4 期

To evaluate the efficacy and in use skin safety of 2 test products [cream containing Sodium Fusidate IP equivalent to Fusidic acid 0.25% w/w in the morning and cream containing Nicotinamide IP 4% w/w in the night] on subjects with moderate facial acne.

Apex Laboratories Pvt Ltd0 个研究点目标入组 42 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
42

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

  • a)Voluntary males/females with moderate inflammatory acne lesions on entire face.
  • b)Above age of 15 years.
  • c)No treatment for acne in the past 1 month
  • d)All skin types (greasy, normal) except sensitive skin.
  • e)Accepting not to use products with the same end benefit during the entire study duration.
  • f)Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
  • g)Having signed a Consent Form/Parent Consent and Child Assent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.

排除标准

  • a)Pregnant women (as confirmed by UPT) and lactating women.
  • b)History suggestive of any hormonal problems.
  • c)History of allergic dermatitis or contact allergy to cosmetics,
  • d)Subjects on oral retinoid since the past 3 months.
  • e)Hypersensitivity to any cosmetic product, raw material.
  • f)For whom the Investigator considers that he/she will not be compliant with study procedures.
  • g)Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.
  • h)Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
  • i)Subject in an exclusion period or participating in another similar cosmetic or therapeutic trial

研究者

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