Single-arm, Open- Label, Randomized, Split-Face Clinical Studyto Assess Safety, Efficacy, In-Use Tolerability and Moisture-kinetics of Rosewater in Healthy Female Subjects

Dabur India Limited0 个研究点目标入组 30 人开始时间: 待定最近更新: 2023年9月18日

试验速览

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•1) Age: 18 to 55 years (both inclusive) old at the time of consent.
•2) Sex: Healthy human non-pregnant/non-lactating females.
•3) Frequent regular users of rosewater.
•4) Females of childbearing potential must have a self-reported negative urine pregnancy test.
•5) Subjects are generally in good general health as determined from recent medical history.
•6) Subjects forearm must be free of cuts, tattoos, scratches, abrasions, scars, uneven skin tone, sunburn, excessive tan, excessive hair or open wounds on or near the test sites.
•7) The subject is willing and able to follow the study directions, participate in the study, returning for all specified visits.
•8) The subject must be able to understand and provide written informed consent to participate in the study.

•1) Subject with known allergy or sensitization to product ingredients rose oil, aloe vera.
•2) The subject has clinically significant skin disease, which may contraindicate participation, including psoriasis, eczema, Skin cancer or other skin pathology.
•3) Subject participation in the study involving the only one application of a personal care product such as lotion or cleansing product to the test area with no invasive procedure within the four weeks prior to enrolment.
•4) Medication which may affect skin response and/or past medical history.
•5) Topical drugs used at the application site.
•6) An individual who has a medical condition or is taking or has taken a medication which, in the Investigator’s judgment, makes the subject ineligible or places the subject at undue risk.
•7) Participation in other clinical studies simultaneously.

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