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Completed

NCT Number: NCT03400202

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

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.

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Key information

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SkinMedica Clinical Research and Innovation Center

Irvine, California, 92612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Skin imaging

Device

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

Facial Cleanser

Other

Facial cleanser prior to procedures.

Other names: SkinMedica Facial Cleanser

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 17, 2018
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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