To evaluation the efficacy of pre bleach cream in Oxy bleach

To evaluate the safety & Efficacy of the Pre-Bleach (new) vs. Pre-bleach(current) in Oxy bleach product.

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/01/011546

Enrollment

Registered

2018-01-24

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 (Oxy bleach cream with pre bleach cream A): Purified Water,Propylene Glycol,Glycerine,Light Liquid Paraffin,Disodium EDTA,Glyceryl stearate, Sodium hydroxide, Triethanolamine,

Eligibility

Inclusion criteria

Inclusion criteria: 1. 44 female subjects in generally good health. 2. Subjects with fitzpatrick skin types II, III and IV. 3. Subjects in 18 to 34 years of age group. 4. Subjects must have used facial bleach at least once. 5. Subjects with clear face without any age/dark spots. 6. Subjects with most sensitive skin having Chromameter reading in the range of 50.00-63.00 as average of cheeks. 7. 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 with excessive facial hair or scars (including acne scars), which could interfere with expert grader and/or instrumental evaluations. 7. Subjects having melasma and severe photo damage. 8. Subjects who are nursing as determined by the investigator interview during screening or pregnant as determined by the Urine pregnancy testing after screening. 9. Subjects with many outdoor activities or who spend a large amount of time daily in the sun. 10. Subjects viewed by the investigator as not being able to complete the study.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety & efficacy of pre bleach cream in Oxy bleach.Timepoint: Day1, Day2, Day3.	—

Secondary

Measure	Time frame
Overall safety of the subject throughout the studyTimepoint: Day1, Day2, Day3.	—

Countries

India

Contacts

Public ContactManmohan Sharma

Dabur India Ltd.

manmohan.sharma@dabur.com01203378591

Outcome results