Physiopathologic Aspects and Quality of Life in Participants With Eye Dark Circles
NCT ID: NCT03400202
Last Updated: 2019-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
44 participants
OBSERVATIONAL
2018-02-02
2018-11-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group A: Dark Circles None
Group A includes participants with Dark Circle Severity Scale score 0 (None). Assessments of the participant's eye dark circles will be made after facial cleansing, utilizing in vivo skin imaging and quality of life questionnaires.
Skin imaging
Non-invasive in vivo skin imaging will be taken with the VivoSight Ox Optical Coherence Tomography (OCT).
Facial cleanser
Facial cleanser prior to procedures.
Group B: Dark Circles Mild
Group B includes participants with Dark Circle Severity Scale score 1 to 3 (Mild). Assessments of the participant's eye dark circles will be made after facial cleansing, utilizing in vivo skin imaging and quality of life questionnaires.
Skin imaging
Non-invasive in vivo skin imaging will be taken with the VivoSight Ox Optical Coherence Tomography (OCT).
Facial cleanser
Facial cleanser prior to procedures.
Group C: Dark Circles Moderate
Group C includes participants with Dark Circle Severity Scale score 4 to 6 (Moderate). Assessments of the participant's eye dark circles will be made after facial cleansing, utilizing in vivo skin imaging and quality of life questionnaires.
Skin imaging
Non-invasive in vivo skin imaging will be taken with the VivoSight Ox Optical Coherence Tomography (OCT).
Facial cleanser
Facial cleanser prior to procedures.
Group D: Dark Circles Severe
Group D includes participants with Dark Circle Severity Scale score 7 to 9 (Severe). Assessments of the participant's eye dark circles will be made after facial cleansing, utilizing in vivo skin imaging and quality of life questionnaires.
Skin imaging
Non-invasive in vivo skin imaging will be taken with the VivoSight Ox Optical Coherence Tomography (OCT).
Facial cleanser
Facial cleanser prior to procedures.
Interventions
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Skin imaging
Non-invasive in vivo skin imaging will be taken with the VivoSight Ox Optical Coherence Tomography (OCT).
Facial cleanser
Facial cleanser prior to procedures.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willingness to not wear any eye makeup on the day of the study visit prior to the study visit appointment
* Willingness to cleanse the face and remove all makeup at least 15 minutes prior to each scheduled clinic visit
* Willingness to have facial exams, skin instrumentation measurements, and digital photos performed on the face.
Exclusion Criteria
* Uncontrolled disease such as diabetes, hypertension, hyper or hypo-thyroidism, active hepatitis, immune deficiency, or autoimmune
* Individuals who have a pre-existing or dormant dermatologic condition (e.g. history of severe psoriasis, atopic dermatitis, rosacea, skin cancer, etc.)
* Individuals who have had a blepharoplasty procedure or any other surgery in proximity or affecting the test area
* Individuals with recent procedures/surgeries (less than 6 months) on the eye bulb
* Individuals with permanent makeup around the eye area
* Chemical peel, microdermabrasion, microneedling, or dermaplaning in the previous 4 weeks
* Latisse, Revitalash, or other lash enhancement stimulators in the previous 1 month
* Retin-A®, Retin-A Micro®, Renova®, Avita®, Tazorac®, Avage® or Differin® or other similar prescription drugs within the previous 3 months
* Cosmetic injections (filler and/or toxins, i.e.Juvederm, Radiesse, Botox, etc.), non- ablative laser or fractional laser resurfacing in the previous 12 months
* Accutane® or other oral retinoid, Ablative procedures (i.e. laser, chemical) in the previous 12 months
* Individuals who have any planned surgeries or procedures during the study.
25 Years
50 Years
ALL
Yes
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa Goberdhan
Role: STUDY_CHAIR
Allergan
Locations
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SkinMedica Clinical Research and Innovation Center
Irvine, California, United States
Countries
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Related Links
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Other Identifiers
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SCRIC17-PHYEYE-01
Identifier Type: -
Identifier Source: org_study_id
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