NCT05807620

A 12 Week Study to Evaluate the Efficacy of an Eye Cream

A Clinical Study to Evaluate the Efficacy and Tolerability of an Eye Cream for Moderate to Severe Dark Circles and Undereye Puffiness

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Revision Skincare · Industry
• Sex: Female
• Age: 35 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This single center, open-label clinical study was conducted to assess the efficacy and tolerance of a topical eye cream when used over the course of 12 weeks by healthy women with moderate to severe under-eye dark circles, moderate under eye puffiness, and mild fine lines and wrinkles. A total of 37 subjects were enrolled into the study.

Detailed description

This single center, open-label clinical study was conducted to evaluate the efficacy and tolerability of an eye cream on healthy female subjects between 35 to 60 years of age with Fitzpatrick Skin Type I - VI, and moderate to severe dark circles and under-eye puffiness. This study aims to evaluate the following objectives: 1. To evaluate the eye cream impact on undereye dark circles, undereye puffiness, fine lines and wrinkles periorbital eye area, and overall appearance periorbital eye area, as evaluated by investigator clinical grading, chromameter, VISIA clinical photography, and subjective questionnaire performed at baseline, week 4, week 8, and week 12. 2. To evaluate the eye cream impact on under eye blood flow, as evaluated by laser doppler performed at baseline, week 8, and week 12. 3. To assess objective and subjective tolerability of Dryness, Erythema, and Edema, and Burning, Stinging, Peeling, and Itching evaluated by investigator and subjective grading at baseline, week 4, week 8, and week 12. A total of 37 subjects completed the study.

Conditions

• Periorbital Hyperpigmentation
• Periorbital Edema
• Fine Lines
• Wrinkle

Interventions

Type	Name	Description
OTHER	Gentle Cleansing Lotion	Facial cleansing lotion to be used by study participants (morning and evening, 2x daily).
OTHER	Facial Moisturizer	Anti-aging facial moisturizer to be used by study participants after anti-aging daily serum before sunscreen (morning and evening, 2x daily).
OTHER	Sunscreen SPF 30	Neutrogena Ultra Sheer Dry Touch SPF 30. Sunscreen to be applied after application of the facial moisturizer in the morning. Participants were asked to reapply every 2 hours. Per FDA this intervention is an over the counter

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-05-01
• Completion: 2022-07-01
• First posted: 2023-04-11
• Last updated: 2023-11-30

Locations

1 site across 1 country: United States