- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05807620
A 12 Week Study to Evaluate the Efficacy of an Eye Cream
A Clinical Study to Evaluate the Efficacy and Tolerability of an Eye Cream for Moderate to Severe Dark Circles and Undereye Puffiness
Study Overview
Status
Intervention / Treatment
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:
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
-
Teaneck, New Jersey, United States, 07666
- Validated Claim Support, LLC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Eye Cream
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. |
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
12 weeks
|
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 |
12 weeks
|
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 |
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 weeks
|
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
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Anna Hardy, Validated Claim Support
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS211024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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