Clinical trial NCT03400202: Physiopathologic Aspects and Quality of Life in Participants With Eye Dark Circles
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periorbital Hyperpigmentation
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2018-01-17
Enrollment: 44
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants at a Clinical Research Center.

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.


Eligibility 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.

Primary outcomes:
measure: Dark Circles Severity Scale Score
timeFrame: Day 1
measure: Classification Type of Dark Circles Score
timeFrame: Day 1
Secondary outcomes:
measure: Subject Questionnaire on Dark Circles, Medical History, and Lifestyle Habits
timeFrame: Day 1
Other outcomes:
Locations:
city: Irvine
country: United States
facility: SkinMedica Clinical Research and Innovation Center
state: California
Study officials:
affiliation: Allergan
name: Lisa Goberdhan
role: STUDY_CHAIR
References: