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| Name | Class |
|---|---|
| Validated Claim Support | UNKNOWN |
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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.
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:
A total of 37 subjects completed the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gentle Cleansing Lotion | Other | Facial cleansing lotion to be used by study participants (morning and evening, 2x daily). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Lack of significant increase in objective investigator tolerability parameters at week 4, 8, and 12 compared to baseline | 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
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| Measure | Description | Time Frame |
|---|---|---|
| Change In Facial parameters in a self-assessment questionnaire versus Baseline and % Agreement | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Hardy | Validated Claim Support | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Validated Claim Support, LLC | Teaneck | New Jersey | 07666 | United States |
Individual participant data will not be shared with other researchers
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| ID | Term |
|---|---|
| D054517 | Orbital Cellulitis |
| ID | Term |
|---|---|
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D002481 | Cellulitis |
| D003240 | Connective Tissue Diseases |
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| 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). |
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| 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 |
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| 12 weeks |
| Lack of significant increase in Subjective investigator tolerability parameters at week 4, 8, and 12 compared to baseline | 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
| 12 weeks |
| 12 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |