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).

Phase 4

Completed

Recruitment & Eligibility

Inclusion Criteria

Female Adult Subjects in general good health as determined from a recent medical

history.

• 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

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of Oxylife Aloevera Gel Bleach in imparting skin fairness and <br/ ><br>luminance in healthy female volunteers of varied skin types (Oily, Dry, Normal and <br/ ><br>Combination) in comparison to baseline.Timepoint: 7 days for each subject

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety of Oxylife Aloevera Gel Bleach. <br/ ><br>To evaluate the efficacy of Oxylife Aloevera Gel Bleach in imparting skin Hydration.Timepoint: 7 days for each subject