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临床试验/CTRI/2018/04/013504
CTRI/2018/04/013504已完成未知

An exploratory study to investigate cleanser formulations for their efficacy on Skinimperfections (acne and skin respect) through instrumental and dermatologist assessment,over a 4 week daily home usage

Oreal India Pvt Ltd0 个研究点目标入组 152 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
152

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. Healthy female Indian volunteers, aged 18 â?? 45 years (both inclusive)
  • 2. Subjects with casual sebum levels >= 80 μg/cm2 and Sebum Excretion Rate >= 50 μg/cm2
  • 3. Subjects having atleast 5 inflammatory and no more than 15 inflammatory lesions over
  • the whole face, out of which atleast 2 are papules of size > 0.5 mm and evolved in last
  • 5 days (basis the medical history)
  • 4. Subjects having at least 10 non-inflammatory acne lesions and not more than 50 non-inflammatory acne lesions over the whole face, out of which at least 50% are open comedones (black heads)
  • 5. Subjects with medium to dark skin color having ITA values between >= 10 and <= 41
  • 6. Subjects having at least two Post Inflammatory Hyper pigmentation spots of size 3 mm or more
  • 7. Subjects with adequate representation of normal and sensitive skin
  • 8. Females with a stable hormonal status, as self-declared by subjects
  • 9. Subject who agrees not to use any other product/treatment/soap bar/any other cleanser
  • on their face during the study period
  • 10. Subject who agrees not to carry out bleaching or any other procedures including facial etc. on face during the study period
  • 11. Subject who agrees to remove all jewellery on/around face (e.g., necklace, earrings,
  • nose ring), during VISIA imaging
  • 12. Female subject with child-bearing potential willing to undergo Urine Pregnancy Test
  • and to use acceptable methods of contraception
  • 13. Subjects who are able to give written informed consent and to comply with the
  • requirements of the study
  • 14. Subjects who are ready to follow instructions and study restrictions during the study period

排除标准

  • 1. Known hypersensitivity to any of the study products or constituents
  • 2. Any significant skin pathology in the test area, like rosacea, severe acne, or eczema
  • 3. Subjects on any topical or systemic treatment that could interfere with the study
  • treatments/assessments (topical benzoyl peroxide and other anti-acne or anti-seborreic
  • products, antibiotics, corticosteroids, retinoids, anti-inflammatory drugsâ?¦) within the
  • last 4 weeks prior to participation in the study, and during the study
  • 4. Subjects who are having chronic illness or had major surgery in the last year
  • 5. Subject with any significant medical condition that would interfere with the
  • participation in the trial
  • 6. Subject who are allergic or sensitive to bar cleansing products/face cleansers/
  • creams/lotions, artificial jewellery or anything else
  • 7. Females in pregnancy or lactation at the beginning of the study or planned during the
  • 8. Subject reported or planning to sun-bathe or to overexpose to UV-light (mountain, sports, phototherapy, tanning salon useâ?¦) for aesthetic or therapeutic reasons the month before the study start or during the study
  • 9. Participation in any other clinical trial up to 1 month prior to screening and during the
  • 10. Any topical or systemic treatment(s) such as NSAIDs, corticosteroids, retinoids,
  • vitamins , etc. that, in the investigatorâ??s judgement, could interfere with the study
  • treatments / assessments, taken 2 weeks prior to inclusion and / or planned during the
  • 11. Subjects Who have started, stopped or changed their hormonal treatment(s) (including
  • contraceptive pill) in the previous one month prior to the study

研究者

发起方
Oreal India Pvt Ltd

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