A phase IV, open label, monocentric, single arm clinical study to evaluate the safety andefficacy of Oxylife Aloevera Gel Bleach in imparting skin fairness and luminance in healthyfemale volunteers of varied skin types (Oily, Dry, Normal and Combination). - Nil

Dabur India Limited0 个研究点目标入组 35 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Female Adult Subjects in general good health as determined from a recent medical
•Subjects in the age group of 18 years and above.
•Subject with Fitzpatrick skin types III to V.
•Subjects willing to give a voluntary written informed consent and agree to come for
•regular follow up.
•Subjects willing to abide by and comply with the study protocol.
•Subjects who have not participated in a similar investigation in the past four weeks.
•Subjects who are willing not to participate in any other clinical trial during participation
•in the current trial.
•Subjects with hyperpigmentation spots such as ephilides, lentigines, melasma, PIH will
•also be included in the study.
•In addition, female subjects selected for the study must:
•Be using a medically acceptable form of birth control for the duration of the study as
•judged by the investigator(s) Or
•Be surgically sterile Or
•Be post menopausal for at least 1 year
•Have a negative urine pregnancy test upon check-in to the study facility.
•Have a negative skin sensitivity test

•Subjects who have:
•Systolic blood pressure less than 90 mm of Hg and more than 140 mm of Hg
•Diastolic blood pressure less than 60 mm of Hg and more than 90 mm of Hg. Minor
•deviations (2-4 mm Hg) at check-in may be acceptable at the discretion of the
•physician /investigator.
•Pulse rate below 60 / minute and above 100/minute.
•Respiratory rate below 14 or above18 breath per minute.
•Oral temperature less than 96.2oF, more than 99.8oF.

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