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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03400202
Recruitment Status : Completed
First Posted : January 17, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
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.

Condition or disease Intervention/treatment
Periorbital Hyperpigmentation Device: Skin imaging Other: Facial cleanser

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Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : February 2, 2018
Actual Primary Completion Date : November 7, 2018
Actual Study Completion Date : November 7, 2018

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 Name: 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 Name: 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 Name: 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 Name: SkinMedica Facial Cleanser




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Participants at a Clinical Research Center.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400202


Locations
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United States, California
SkinMedica Clinical Research and Innovation Center
Irvine, California, United States, 92612
Sponsors and Collaborators
Allergan
Investigators
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Study Chair: Lisa Goberdhan Allergan
Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03400202    
Other Study ID Numbers: SCRIC17-PHYEYE-01
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Hyperpigmentation
Pigmentation Disorders
Skin Diseases