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临床试验/CTRI/2022/05/042840
CTRI/2022/05/042840尚未招募未知

To evaluate the comedogenic effect of skincare formulation Photostable new formulation-OCTCB on healthy human female subjects

Sun Pharmaceutical Industries 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
未知
状态
尚未招募

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

  • 1Indian female subjects
  • 2Healthy 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)
  • 3Between 18 and 35 years of age.
  • 4Skin is healthy on the studied anatomic unit (e.g. free of eczema, wounds, inflammatory scar)
  • 5Having oily or mixed oily skin type on the face (Visual assessment by dermatologist)

排除标准

  • 1Being pregnant 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)
  • 6Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
  • 7Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
  • 8Being epileptic.
  • 9Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
  • 10Having cutaneous hypersensitivity.
  • 11Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
  • 12Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
  • 13Having changed her cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit.
  • 14Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted)
  • 15Having applied hair oil during the entire duration of the study.
  • 16In the previous 6 months
  • -Having started, changed or stopped a hormonal treatment (e.g. hormonal contraception, cyproterone acetate)
  • -Having taken an oral retinoid-based treatment
  • -Having undergone a physical (e.g., phototherapy, laser) or chemical (peeling) treatment for acne
  • 17In the previous 1 month
  • -Having had a local benzoyl-peroxide-based treatment or a local retinoid-based treatment
  • -Having had an oral treatment with a base of cimetidine, zinc (zinc gluconate) or spironolactone
  • 18In the previous 2 weeks
  • -Having applied cosmetic products with anti-seborrheic aims or cosmetics for oily skin
  • -Having had oral or local antibiotic treatment for acne
  • 19In the previous 1 week
  • -Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask)
  • -Having a suntanned skin on the studied areas which could interfere with the evaluations of the stud

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