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

Not Applicable

Completed

• Conditions: Periorbital Hyperpigmentation; Periorbital Edema; Wrinkle; Fine Lines
• Interventions: Other: Gentle Cleansing Lotion; Other: Facial Moisturizer; Other: Sunscreen SPF 30

• Registration Number: NCT05807620
• Lead Sponsor: Revision Skincare

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.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-07-01
• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-03-29
• Study First Posted: 2023-04-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eye Cream	Gentle Cleansing Lotion	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.
Eye Cream	Facial Moisturizer	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.
Eye Cream	Sunscreen SPF 30	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.

Primary Outcome Measures

Name	Time	Method
Change in Investigator Clinical Grading versus Baseline	12 weeks	The primary efficacy endpoint will be investigator clinical grading using a Modified Griffiths 10 point scale and a validated photonumeric scale for undereye dark circles; A decrease in scores at post baseline timepoints (weeks 4, 8, and 12) in comparison to baseline indicates an improvement for the indicated parameter.; The efficacy parameters will be assessed globally on each subject's face using a validated photonumeric scale for dark circles and Modified Griffiths 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition): 0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate; 7 to 9 = severe (worst possible condition). The lower the score equates to the best possible outcome.
Bioinstrumentation: Chromameter	12 weeks	Bioinstrumentation measurements includes Chroma Meter CR-200 (Konica Minolta, Tokyo, JPN); Measurements were taken on the right or left undereye area, per randomization on each subject in triplicate and averaged at baseline, week 4, 8 and 12. Three color value characteristics are evaluated: L\* (100 = white, 0 = black) and a\* (red-green); An increase in L\* indicates an improvement A decrease in a\* indicates an improvement
Bioinstrumentation: Laser Doppler	12 weeks	Bioinstrumentation measurements includes INL 191 Blood FlowMeter laser doppler; A standard surface probe approximately 17mm in diameter was placed on the right or left undereye area per randomization and measurements in perfusion units (AU) were obtained at baseline week 8 and week 12.; An increase in AU values indicates an improvement in dark circles

Secondary Outcome Measures

Name	Time	Method
Lack of significant increase in Subjective investigator tolerability parameters at week 4, 8, and 12 compared to baseline	12 weeks	The secondary tolerability endpoint will be the Subjective Tolerability Assessment of Stinging, Tingling, Itching, and Burning; A decrease in scores or lack of significant increase at week 4, 8, and 12 in comparison to Baseline indicates tolerability/safety of the test material. Four point scale with a lower score indicating a better outcome.; Example Burning.; 0 = None; 1. = Mild; 2. = Moderate; 3. = Severe
Lack of significant increase in objective investigator tolerability parameters at week 4, 8, and 12 compared to baseline	12 weeks	The second outcome measure is objective tolerability endpoint. Investigator Tolerability Assessment includes Erythema, Edema and Dryness.; A decrease in scores or lack of significant increase at week 4, 8, and 12 in comparison to Baseline indicates tolerability/safety of the test material. Five point scale with a lower score indicating a better outcome.; Example for Erythema: Erythema 0 = None No erythema of the treatment area; 1. = very slight erythema (barely perceptible); 2. = well-defined erythema; 3. = Moderate to severe erythema; 4. = Severe erythema (beet redness) to slight eschar formation

Trial Locations

Locations (1)

Validated Claim Support, LLC; 🇺🇸 Teaneck, New Jersey, United States