NCT05160103

16-Week Randomized Split-Face Efficacy Study of Cosmetic Formulations in Photoaged Pigmented Skin Subjects

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Avon Products, Inc. · Industry
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to determine the efficacy of seven different formulations currently marketed and commercially available cosmetic products on skin tone evenness, post-inflammatory hyperpigmentation, and discrete pigmentation in females of Fitzpatrick skin types IV-VI.

Detailed description

This is a single site, double-blind randomized, split face, efficacy study. All subjects will receive a cleanser, Day Cream/sunscreen, and two treatment products. The treatment products will be applied in a split face fashion including behind the ear. Local volunteer subjects will be enrolled such that a total of eighty-four (84) subjects will complete the study; with 24 subjects completing in each treatment. Each subject will receive a cleanser, Day Cream/sunscreen and two treatment products as per the randomization. Subjects will use the cleanser twice daily, Day Cream/sunscreen in the morning, and the treatment products as specified after cleansing in the evening, for a period of 16 weeks. Clinical assessments, non-invasive instrument measurements and photographs will be completed at baseline and weeks 4, 8, 12, and 16. Biopsies will be taken at baseline and Week 16.

Conditions

• Aging Problems
• Pigmentation

Interventions

Type	Name	Description
OTHER	Cosmetic Formulations	Topical emulsions containing anti-aging ingredients

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-04-01
• Completion: 2022-05-01
• First posted: 2021-12-16
• Last updated: 2021-12-16