To evaluate the safety and efficacy of facial bleaches on healthy human subjects.

A double blinded, comparator controlled, randomized single center clinical study to evaluate the safety and efficacy of facial bleach formulations in improving and retaining skin fairness on healthy human subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/01/011379

Enrollment

220

Registered

2018-01-16

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: Product A (OXYLIFE CREME BLEACH): Aqua, Hydrogen peroxide, Cetostearyl Alcohol, Propylene Glycol, Polyoxyethylene 20 Cetostearyl Alcohol, PEG 100 Stearate, Glyceryl Monostearate, Steari

Eligibility

Inclusion criteria

Inclusion criteria: 1.220 female & Male subjects in generally good health. 2.Subjects in 18 to 34 years of age group. 3.Subjects must have used facial bleach at least once. 4.Subjects with clear face without any age/dark spots. 5.Subjects having Chromameter reading in the range of 50.00-61.00 as average of cheeks, forehead and chin. 6.Out of 160 subjects, 40 with Most Sensitive Skin. 7.Out of 160 subjects, 40 with young and sensitive Skin. 8.Out of 160 subjects, 20 with wheatish Skin Complexion. 9.Out of 160 subjects, 40 with Fairer Skin Complexion. 10.Out of 160 subjects, 20 male subjects. 11.Subjects willing to give a written informed consent and come for regular follow up.

Exclusion criteria

Exclusion criteria: 1.Subjects with known allergies or sensitivities to cosmetic products, toiletries or its components like fragrances, preservatives, hydroquinone, vitamin C, Niacin amide, retinol, soy etc. 2.Currently or has been using topical retinoids, alpha-hydroxy and/or beta-hydroxy acids, hydroquinone or any whitening/Fairness preparation in any form (cleanser, toner, facial lotion, cream or soaps) within the last 1 month. 3.Currently or has been undergoing dermatologist facial treatments or procedures within the last 1 month. 4.Currently or has been involved in another facial skin care clinical investigation within the last 3 months. 5.Subjects who have pre-existing or dormant facial dermatologic conditions (e.g., psoriasis, rosacea, rashes, eczema, many and/or severe excoriations etc.) that could interfere with the outcome of the study as determined by the investigator. 6.Subjects who have a medical history of disease or condition or a concurrent illness that could affect the outcome of the study. 7.Subjects with excessive facial hair or scars (including acne scars), which could interfere with expert grader and/or instrumental evaluations.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety & efficacy of bleaches in fairness, glow the skin.Timepoint: Day 1,Day 2, Day3.	—

Secondary

Measure	Time frame
Safety of the subject throughout the studyTimepoint: Day 1,Day 2, Day3.	—

Countries

India

Contacts

Public ContactMANMOHAN SHARMA

Dabur India Ltd.

manmohan.sharma@dabur.com01203378591

Outcome results