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

January 21, 2019 updated by: Allergan

Eye Dark Circles: Physiopathologic Aspects and Influence on Quality of Life in Subjects of Various Ethnicities and Fitzpatrick Skin Types Utilizing Non-invasive In Vivo Instrumentation and Validated Questionnaires

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92612
        • Skinmedica Clinical Research and Innovation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants at a Clinical Research Center.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Skin imaging
Non-invasive in vivo skin imaging will be taken with the VivoSight Ox Optical Coherence Tomography (OCT).
Other: Facial cleanser
Facial cleanser prior to procedures.
Other Names:
  • SkinMedica Facial Cleanser
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.
Device: Skin imaging
Non-invasive in vivo skin imaging will be taken with the VivoSight Ox Optical Coherence Tomography (OCT).
Other: Facial cleanser
Facial cleanser prior to procedures.
Other Names:
  • SkinMedica Facial Cleanser
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.
Device: Skin imaging
Non-invasive in vivo skin imaging will be taken with the VivoSight Ox Optical Coherence Tomography (OCT).
Other: Facial cleanser
Facial cleanser prior to procedures.
Other Names:
  • SkinMedica Facial Cleanser
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.
Device: Skin imaging
Non-invasive in vivo skin imaging will be taken with the VivoSight Ox Optical Coherence Tomography (OCT).
Other: Facial cleanser
Facial cleanser prior to procedures.
Other Names:
  • SkinMedica Facial Cleanser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dark Circles Severity Scale Score
Time Frame: Day 1
The investigator will access the participant's lower and upper eyelids using the Dark Circles Severity Scale where 0=None to 9=Severe (very dark circles).
Day 1
Classification Type of Dark Circles Score
Time Frame: Day 1
The investigator will assess the lower eyelids for the following types of dark circles: Pigmented, Vascular and Shadow Effect. Each of these 3 types are graded where 0=none to 3=severe.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject Questionnaire on Dark Circles, Medical History, and Lifestyle Habits
Time Frame: Day 1
The Subject Questionnaire on Dark Circles, Medical History and Lifestyle Habits is a 15-item questionnaire completed by the participant.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Chair: Lisa Goberdhan, Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 2, 2018

Primary Completion (ACTUAL)

November 7, 2018

Study Completion (ACTUAL)

November 7, 2018

Study Registration Dates

First Submitted

January 11, 2018

First Submitted That Met QC Criteria

January 11, 2018

First Posted (ACTUAL)

January 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 21, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCRIC17-PHYEYE-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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