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

Revision Skincare

Status: Completed

Conditions: Periorbital Hyperpigmentation; Fine Lines; Periorbital Edema; Wrinkle

Treatments: Other: Sunscreen SPF 30; Other: Gentle Cleansing Lotion; Other: Facial Moisturizer

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05807620

CS211024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Females in good general health
• With Fitzpatrick Skin Type I - VI
• Moderate to severe under eye dark circles
• Moderate undereye puffiness
• Mild to moderate fine lines and wrinkles

Exclusion criteria

• Subjects who have used retinol or eye cream / serum 7 days prior to study commencement
• Nursing, pregnant, or planning a pregnancy during this study
• Having a health condition and / or pre-existing or dormant dermatologic disease on the face

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Eye Cream

Experimental group

Description:

Eye Cream composed of botanical extracts, bioavailable peptides, THD Ascorbate and Caffeine. Subjects to apply a dime size amount onto the under-eye area and crow's feet area while avoiding direct eye contact twice daily for the duration of the 12-week clinical study.

Treatment:

Other: Facial Moisturizer

Other: Sunscreen SPF 30

Other: Gentle Cleansing Lotion