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
| Registry | NCT03400202 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 44 (Actual) |
| Sponsor | Allergan (Industry) |
| Conditions | Periorbital Hyperpigmentation |
| Interventions | Skin imaging, Facial cleanser (Device, other) |
| Dates | start 2018-02-02, primary completion 2018-11-07, completion 2018-11-07, first posted 2018-01-17, last updated 2019-01-23 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Periorbital Hyperpigmentation All trials of Skin imaging All trials of Facial cleanser
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group A: Dark Circles None | Device: Skin imaging; Other: Facial cleanser | 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. | |
| Group B: Dark Circles Mild | Device: Skin imaging; Other: Facial cleanser | 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. | |
| Group C: Dark Circles Moderate | Device: Skin imaging; Other: Facial cleanser | 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. | |
| Group D: Dark Circles Severe | Device: Skin imaging; Other: Facial cleanser | 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. |
Sex: All, ages: 25 Years to 50 Years, 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.
| Facility | City | Country | Status |
|---|---|---|---|
| SkinMedica Clinical Research and Innovation Center | Irvine, California | United States |