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

Periorbital Hyperpigmentation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400202
• Other study ID #: SCRIC17-PHYEYE-01
• Status: Completed
• Start date: February 2, 2018
• Est. completion date: November 7, 2018

Study information

• Verified date: January 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 7, 2018
• Est. primary completion date: November 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperpigmentation
• Periorbital Hyperpigmentation

Intervention

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

Other:
• Facial cleanser
Facial cleanser prior to procedures.

Locations

Country	Name	City	State
United States	SkinMedica Clinical Research and Innovation Center	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Subject Questionnaire on Dark Circles, Medical History, and Lifestyle Habits	The Subject Questionnaire on Dark Circles, Medical History and Lifestyle Habits is a 15-item questionnaire completed by the participant.	Day 1

External Links

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