Clinical trial NCT05807620: A 12 Week Study to Evaluate the Efficacy of an Eye Cream
Official title: A Clinical Study to Evaluate the Efficacy and Tolerability of an Eye Cream for Moderate to Severe Dark Circles and Undereye Puffiness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periorbital Hyperpigmentation
Periorbital Edema
Fine Lines
Wrinkle
Keywords: dark circles
puffiness
brightening
Lead sponsor: Revision Skincare
Sponsor class: INDUSTRY
Collaborators: name: Validated Claim Support
First posted: 2023-04-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Investigator Clinical Grading versus Baseline
timeFrame: 12 weeks
measure: Bioinstrumentation: Laser Doppler
timeFrame: 12 weeks
measure: Bioinstrumentation: Chromameter
timeFrame: 12 weeks
Secondary outcomes:
measure: Lack of significant increase in objective investigator tolerability parameters at week 4, 8, and 12 compared to baseline
timeFrame: 12 weeks
measure: Lack of significant increase in Subjective investigator tolerability parameters at week 4, 8, and 12 compared to baseline
timeFrame: 12 weeks
Other outcomes:
measure: Change In Facial parameters in a self-assessment questionnaire versus Baseline and % Agreement
timeFrame: 12 weeks
Locations:
city: Teaneck
country: United States
facility: Validated Claim Support, LLC
state: New Jersey
Study officials:
affiliation: Validated Claim Support
name: Anna Hardy
role: STUDY_DIRECTOR
References: