An interventional study of Gentle Cleansing Lotion and Facial Moisturizer in Periorbital Hyperpigmentation, Periorbital Edema and Fine Lines, sponsored by Revision Skincare. Completed at 1 site in United States. Open to female participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-30.
Sponsored by Revision Skincare · Not applicable, Interventional, and Treatment
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.
102 studies on the registry are indexed under Hyperpigmentation; 20 are open to participants now.
This study's enrollment of 40 is close to the median of 38 across 89 interventional studies indexed under Hyperpigmentation.
Browse Hyperpigmentation studies →Revision Skincare is the lead sponsor of 17 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
Facial cleansing lotion to be used by study participants (morning and evening, 2x daily).
Anti-aging facial moisturizer to be used by study participants after anti-aging daily serum before sunscreen (morning and evening, 2x daily).
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
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.
Time frame: 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
Time frame: 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
Time frame: 12 weeks
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 1. = very slight erythema (barely perceptible) 2. = well-defined erythema 3. = Moderate to severe erythema 4. = Severe erythema (beet redness) to slight eschar formation
Time frame: 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 1. = Mild 2. = Moderate 3. = Severe
Time frame: 12 weeks
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.
Time frame: 12 weeks
Plan to share: No — Individual participant data will not be shared with other researchers
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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