An Open-Label Clinical Study to Evaluate the Efficacy of a Face Cream and Eye Cream

Revision Skincare

Status

Completed

Conditions

Fine Lines

Photoaging

Wrinkle

Treatments

Other: Gentle Cleansing Lotion, Revision Skincare

Other: Aveeno Face Milk SPF 40+

Study type

Interventional

Funder types

Industry

Identifiers

NCT04911374

C20-D134

Details and patient eligibility

About

This single-center clinical trial is being conducted to assess the efficacy and tolerability of an anti-aging eye cream and face moisturizer when used over the course of 12 weeks twice-daily by women, 35-65 years, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global facial photodamage.

Full description

This was an institutional review board (IRB)-approved study. Female subjects, 35-65 years of age, Fitzpatrick skin type I-VI, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global photodamage were recruited. Subjects applied a multi-ingredient anti-aging face moisturizer and eye twice-daily for 12 weeks. Subjects were provided with a gentle cleansing lotion and a sunscreen SPF 40+ to be utilized during the course of the study.

Clinical grading of efficacy and tolerability parameters, VISIA-CR imaging, raking light VISIA analysis, skin pH, Tewameter, and pinch recoil measurements were performed at baseline, weeks 4, 8, and 12. Optical coherence tomography (OCT) imaging was performed at baseline and week 12.

A total of 42 subjects completed the study.

Enrollment

45 patients

Sex

Female

Ages

35 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Women between the ages of 35 and 65 years
Women with Fitzpatrick skin type I-VI
Subjects must have mild to droopy eyelids, moderate crow's feet wrinkles, and moderate photodamage
Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
Subjects must be willing to provide verbal understanding and written informed consent.

Exclusion criteria

Subjects which had a health condition and/or pre-existent dormant dermatological disease on the face
Subjects that had any invasive or non-invasive skin treatments, or invasive medical procedures three months prior to the study
Subjects that are unwilling to comply with the protocol
Female subjects who are pregnant, breast feeding, or planning a pregnancy.
Subjects who have any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin, including rosacea, acne, and excessively oily or dry skin.
Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
Subjects use of any medications that are known to potentially cause changes in the facial skin as determined by the Investigator.
Subjects who spend excessive time out in the sun.