CTRI/2019/07/020044已完成未知
A study to evaluate the safety of investigational product by repeat use test (14 days) in healthy female subjects of varied skin types (normal, dry, oily and combination)
ITC Life Sciences Technology Centre0 个研究点目标入组 40 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
- 40
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 non-pregnant/ non-lactating female subjects in the age group of 18-40 years (inclusive of both ages).
- •2. Females of childbearing potential must have a negative urine pregnancy test performed on screening visit.
- •3. Subjects willing to abide by the study protocol and restrictions.
- •4. Subjects with different skin types: normal, dry, oily and combination in nearly equal ratio.
- •5. About 20 Subjects who use contact lens for a period of 6-8 hrs daily.
- •6. Subjects with good general health as determined by the Investigator on the basis of medical history.
- •7. Subjects willing to give a voluntary written informed consent.
- •8. Subjects willing to use their own eye and lip make-up products, for the duration of the study.
- •9. Subjects having not participated in a similar investigation in the past two weeks.
- •10. Subjects willing to come for regular follow up visits.
- •11. Subjects ready to follow instructions during the study period.
排除标准
- •1. Subject is either pregnant/ planning a pregnancy, or lactating.
- •2. Subject having known history or present condition of allergic response to any cosmetic products (face/eye)/ known or suspected intolerance to cosmetic ingredients including fragrance
- •3. Subject having any eye infection or allergy/ extremely sensitive eye condition.
- •4. Subject having any form of cutaneous disease which may influence the study result.
- •5. Previous history of atopy with regards to allergic reactions, irritation or intense discomfort feelings to topical-use products, cosmetics or medication
- •6. Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational product and/or interfere with the evaluation of the test site reaction
- •7. Presence of open sores, pimples, or cysts at the application site
- •8. Subject having history of/or currently using medication (topical or systemic medications, oral or topical treatment with Vit. A and/or its derivatives, or allergy injections) which in the opinion of the investigator may affect the evaluation of the study product, or place the participant at undue risk.
- •9. Participation in another clinical study (including cosmetic/ drug studies) or studies with a similar application site, within 30 days of the screening visit.
- •10. Any participant who, in the judgment of the Investigator, should not participate in the study.
- •11. Any participant with corneal ulcers, keratoconus, blepharitis, meibomitis, pterygium, chemosis, moderately or severe hyperemia or other active ocular diseases.
- •12. Any participant having skin marks on their face that might interfere with the evaluation of possible skin reactions as per dermatologist.
- •13. An employee of the sponsor or the study site.
研究者
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