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Completed

NCT Number: NCT05807620

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

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.

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Key information

Conditions

Periorbital Hyperpigmentation Cellulitis Connective Tissue Diseases Eye Diseases Fine Lines Orbital Cellulitis Orbital Diseases Periorbital Edema Skin and Connective Tissue Diseases Wrinkle

Age range

35 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Validated Claim Support, LLC

Teaneck, New Jersey, 07666, United States

About this study

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:

  • 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.
  • To evaluate the eye cream impact on under eye blood flow, as evaluated by laser doppler performed at baseline, week 8, and week 12.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gentle Cleansing Lotion

Other

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

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).

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

Primary outcomes

  1. Change in Investigator Clinical Grading versus Baseline

    Time frame: 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.

  2. Bioinstrumentation: Laser Doppler

    Time frame: 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

  3. Bioinstrumentation: Chromameter

    Time frame: 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

Secondary outcomes

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

    Time frame: 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

    • = very slight erythema (barely perceptible)
    • = well-defined erythema
    • = Moderate to severe erythema
    • = Severe erythema (beet redness) to slight eschar formation

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

    Time frame: 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

    • = Mild
    • = Moderate
    • = Severe

Other outcomes

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

    Time frame: 12 weeks

    Self-Assessment Questionnaire and the Subject Treatment Satisfaction. A decrease or increase in response values at week 4, 8, and 12, and indicates an improvement compared to baseline response values.

    Subjects are asked to rate based on a scoring system of the following:

    from 5 (completely agree) to 1 (completely disagree). The best outcome is to Completely Agree with the statement/ question being asked.

Sponsors and collaborators

Lead sponsor

Revision Skincare

Industry

Collaborators

  • Validated Claim Support

Registry information

Official study title

A Clinical Study to Evaluate the Efficacy and Tolerability of an Eye Cream for Moderate to Severe Dark Circles and Undereye Puffiness

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 11, 2023
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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