An exploratory study to check the effectiveness of face cleanser formulations on skin imperfections through multiple instruments and assessment by the investigator

Not Applicable

Completed

• Registration Number: CTRI/2018/04/013504
• Lead Sponsor: Oreal India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-08-03
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 152

Inclusion Criteria

1. Healthy female Indian volunteers, aged 18 â?? 45 years (both inclusive)

2. Subjects with casual sebum levels >= 80 μg/cm2 and Sebum Excretion Rate >= 50 μg/cm2

3. Subjects having atleast 5 inflammatory and no more than 15 inflammatory lesions over

the whole face, out of which atleast 2 are papules of size > 0.5 mm and evolved in last

5 days (basis the medical history)

4. Subjects having at least 10 non-inflammatory acne lesions and not more than 50 non-inflammatory acne lesions over the whole face, out of which at least 50% are open comedones (black heads)

5. Subjects with medium to dark skin color having ITA values between >= 10 and <= 41

6. Subjects having at least two Post Inflammatory Hyper pigmentation spots of size 3 mm or more

7. Subjects with adequate representation of normal and sensitive skin

8. Females with a stable hormonal status, as self-declared by subjects

9. Subject who agrees not to use any other product/treatment/soap bar/any other cleanser

on their face during the study period

10. Subject who agrees not to carry out bleaching or any other procedures including facial etc. on face during the study period

11. Subject who agrees to remove all jewellery on/around face (e.g., necklace, earrings,

nose ring), during VISIA imaging

12. Female subject with child-bearing potential willing to undergo Urine Pregnancy Test

and to use acceptable methods of contraception

13. Subjects who are able to give written informed consent and to comply with the

requirements of the study

14. Subjects who are ready to follow instructions and study restrictions during the study period

Exclusion Criteria

1. Known hypersensitivity to any of the study products or constituents

2. Any significant skin pathology in the test area, like rosacea, severe acne, or eczema

3. Subjects on any topical or systemic treatment that could interfere with the study

treatments/assessments (topical benzoyl peroxide and other anti-acne or anti-seborreic

products, antibiotics, corticosteroids, retinoids, anti-inflammatory drugsâ?¦) within the

last 4 weeks prior to participation in the study, and during the study

4. Subjects who are having chronic illness or had major surgery in the last year

5. Subject with any significant medical condition that would interfere with the

participation in the trial

6. Subject who are allergic or sensitive to bar cleansing products/face cleansers/

creams/lotions, artificial jewellery or anything else

7. Females in pregnancy or lactation at the beginning of the study or planned during the

study

8. Subject reported or planning to sun-bathe or to overexpose to UV-light (mountain, sports, phototherapy, tanning salon useâ?¦) for aesthetic or therapeutic reasons the month before the study start or during the study

9. Participation in any other clinical trial up to 1 month prior to screening and during the

study

10. Any topical or systemic treatment(s) such as NSAIDs, corticosteroids, retinoids,

vitamins , etc. that, in the investigatorâ??s judgement, could interfere with the study

treatments / assessments, taken 2 weeks prior to inclusion and / or planned during the

study

11. Subjects Who have started, stopped or changed their hormonal treatment(s) (including

contraceptive pill) in the previous one month prior to the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified