To evaluate the safety and efficacy of Oxylife Aloevera Gel Bleach in imparting skin fairness and luminance in healthy female volunteers of varied skin types (Oily, Dry, Normal and Combination).

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2013/04/003523

Enrollment

Registered

2013-04-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Oxylife Aloevera Gel Bleach: application of product for bleaching the entire face and neck of each subject. Dose- only at visit 2 bleaching will be done. Duration- 7 days for each subje

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
To evaluate the safety of Oxylife Aloevera Gel Bleach. To evaluate the efficacy of Oxylife Aloevera Gel Bleach in imparting skin Hydration.Timepoint: 7 days for each subject	—

Countries

India

Contacts

Public ContactDr Mukesh Ramnane

MS Clinical Research Pvt Ltd.

mukesh.ramnane@mscr.in918040917253

Outcome results