Physiopathologic Aspects and Quality of Life in Participants With Eye Dark Circles

NCT ID: NCT03400202

Last Updated: 2019-01-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-02

Study Completion Date

2018-11-07

Brief Summary

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This study will evaluate the physiopathologic characteristics of dark circles in participants with various ethnicities and Fitzpatrick Skin Types and the impact of the dark circles on the quality of life.

Detailed Description

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Conditions

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Periorbital Hyperpigmentation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type DEVICE

Non-invasive in vivo skin imaging will be taken with the VivoSight Ox Optical Coherence Tomography (OCT).

Facial cleanser

Intervention Type OTHER

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

Intervention Type DEVICE

Non-invasive in vivo skin imaging will be taken with the VivoSight Ox Optical Coherence Tomography (OCT).

Facial cleanser

Intervention Type OTHER

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

Intervention Type DEVICE

Non-invasive in vivo skin imaging will be taken with the VivoSight Ox Optical Coherence Tomography (OCT).

Facial cleanser

Intervention Type OTHER

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

Intervention Type DEVICE

Non-invasive in vivo skin imaging will be taken with the VivoSight Ox Optical Coherence Tomography (OCT).

Facial cleanser

Intervention Type OTHER

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).

Intervention Type DEVICE

Facial cleanser

Facial cleanser prior to procedures.

Intervention Type OTHER

Other Intervention Names

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SkinMedica Facial Cleanser

Eligibility Criteria

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Inclusion Criteria

* Participants with Fitzpatrick skin type I-VI
* 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

* Individuals with active symptoms of allergy, cold sore or warts, active psoriasis or eczema, rosacea, sunburn, open wounds, neurotic excoriations, excessive scarring, tattoos, or other skin conditions in the test area
* 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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Related Links

Other Identifiers

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SCRIC17-PHYEYE-01

Identifier Type: -

Identifier Source: org_study_id

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