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

Allergan

Status: Completed

Conditions: Periorbital Hyperpigmentation

Treatments: Device: Skin imaging; Other: Facial cleanser

Study type: Observational

Funder types: Industry

Identifiers

NCT03400202

SCRIC17-PHYEYE-01

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

44 participants in 4 patient groups

Group A: Dark Circles None

Description:

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.

Treatment:

Device: Skin imaging

Other: Facial cleanser

Group B: Dark Circles Mild

Description:

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.

Treatment:

Device: Skin imaging

Other: Facial cleanser

Group C: Dark Circles Moderate

Description:

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.

Treatment:

Device: Skin imaging

Other: Facial cleanser

Group D: Dark Circles Severe

Description:

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.

Treatment:

Device: Skin imaging

Other: Facial cleanser