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

NCT05807620 | Completed

• 1 other identifier: CS211024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Periorbital Hyperpigmentation; Periorbital Edema; Fine Lines; Wrinkle

Keywords

dark circles; puffiness; brightening

Outcome Measures

Primary Outcomes (3)

• Change in Investigator Clinical Grading versus Baseline

  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.

  12 weeks

• Bioinstrumentation: Laser Doppler

  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

  12 weeks

• Bioinstrumentation: Chromameter

  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

  12 weeks

Secondary Outcomes (2)

• Lack of significant increase in objective investigator tolerability parameters at week 4, 8, and 12 compared to baseline

  12 weeks

• Lack of significant increase in Subjective investigator tolerability parameters at week 4, 8, and 12 compared to baseline

  12 weeks

Other Outcomes (1)

• Change In Facial parameters in a self-assessment questionnaire versus Baseline and % Agreement

  12 weeks

Study Arms (1)

Eye Cream

EXPERIMENTAL

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.

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

Interventions

Gentle Cleansing Lotion OTHER

Facial cleansing lotion to be used by study participants (morning and evening, 2x daily).

Eye Cream

Facial Moisturizer OTHER

Anti-aging facial moisturizer to be used by study participants after anti-aging daily serum before sunscreen (morning and evening, 2x daily).

Eye Cream

Sunscreen SPF 30 OTHER

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

Eye Cream

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Revision Skincare: lead
• Validated Claim Support: collaborator

Study Sites (1)

Validated Claim Support, LLC

Teaneck, New Jersey, 07666, United States

Location

MeSH Terms

Conditions

Orbital Cellulitis

Condition Hierarchy (Ancestors)

Orbital Diseases; Eye Diseases; Cellulitis; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Anna Hardy

  Validated Claim Support

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 11, 2023
• Study Start: January 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: July 1, 2022
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)