Study of effectiveness of a cream in lightening the skin and reducing dark spots in healthy Indian female volunteers having dark spots and dull skin, for 8 weeks

Not Applicable

Completed

• Registration Number: CTRI/2013/04/003558
• Lead Sponsor: Oreal India Pvt Ltd Research Innovation R I

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2013-11-23
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 65

Inclusion Criteria

• Indian female subjects, aged 18-60 years (approximately 80% of total population is between 18 to 45 years age)

• All skin types (50% having sensitive skin) e.g. fair, wheatish, brown and dark brown with equal distribution of skin type across the group

• Subjects having pigmented spots and at least 1 well defined and homogenous spot <= 3mm with an adjacent spotless area, a dull skin tone

on face and visible pores on cheek, presenting vascular homogeneity

• Subjects not applying any skin whitening product prior to 6 weeks of the start of the study

• Able to give written informed consent and to comply with the requirements of the study

Exclusion Criteria

• Any significant skin pathology in the test areas, like rosacea, severe acne, eczema & melasma

• Known hypersensitivity to the any of the study products or constituents

• Any topical or systemic treatment that could interfere with the study treatments/assessments (antibiotics, corticosteroids, retinoids, antiinflammatory drugsâ?¦) within the last 4 weeks prior to participation in the study, and during the study

• Any surgical treatment on the test areas (laser peel, dermabrasion, etc.)

• Subject reported or planning to sun-bath or to overexpose to UV-light (mountains sports, phototherapy, tanning salon use, etc.) for aesthetic or therapeutic reason the month before the study start or during the study

• Any significant medical condition that would interfere in the participation in the trial

• Participation in a clinical trial up to 1 month prior to inclusion

• Pregnant women (as confirmed by UPT) and lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified