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

NCT03400202 | Completed FDA Device

• 1 other identifier: SCRIC17-PHYEYE-01
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Periorbital Hyperpigmentation

Outcome Measures

Primary Outcomes (2)

• Dark Circles Severity Scale Score

  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

  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 Outcomes (1)

• Subject Questionnaire on Dark Circles, Medical History, and Lifestyle Habits

  Day 1

Study Arms (4)

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; Other: 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; Other: 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; Other: 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; Other: Facial cleanser

Interventions

Skin imaging DEVICE

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

Group A: Dark Circles None; Group B: Dark Circles Mild; Group C: Dark Circles Moderate; Group D: Dark Circles Severe

Facial cleanser OTHER

Facial cleanser prior to procedures.

Also known as: SkinMedica Facial Cleanser

Group A: Dark Circles None; Group B: Dark Circles Mild; Group C: Dark Circles Moderate; Group D: Dark Circles Severe

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Participants at a Clinical Research Center.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

SkinMedica Clinical Research and Innovation Center

Irvine, California, 92612, United States

Location

Related Links

• Related Info

Study Officials

• Lisa Goberdhan

  Allergan

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 17, 2018
• Study Start: February 2, 2018
• Primary Completion: November 7, 2018
• Study Completion: November 7, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

US (1)