Periorbital HyperpigmentationNCT03400202
Physiopathologic Aspects and Quality of Life in Participants With Eye Dark Circles
An observational study of Periorbital Hyperpigmentation, run by Allergan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periorbital Hyperpigmentation
- What is being tested?
- Skin imaging and Facial cleanser
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2018to 7 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants at a Clinical Research Center.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
SkinMedica Clinical Research and Innovation Center
Irvine, California, 92612
About this study
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
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
- Being tested
- Skin imaging, Facial cleanser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin imagingDevice
Non-invasive in vivo skin imaging will be taken with the VivoSight Ox Optical Coherence Tomography (OCT).
Facial cleanserOther
Also called SkinMedica Facial Cleanser
Facial cleanser prior to procedures.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Skin imaging; Other: Facial cleanser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Day 1
Secondary outcomes (1)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start2 Feb 2018
- Primary completion7 Nov 2018
- Study completion7 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periorbital HyperpigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Goberdhan, Study chair, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400202
- Sponsor's protocol ID
- SCRIC17-PHYEYE-01
- Status last verified
- Jan 2019
- First submitted
- 11 Jan 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03400202
- Acronym / sponsor ID
- SCRIC17-PHYEYE-01
- Conditions
- Periorbital Hyperpigmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 7 Nov 2018 (actual)
- Study completion
- 7 Nov 2018 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: Dark Circles None | – | Device: Skin imaging, Other: Facial cleanserGroup 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 cleanserGroup 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 cleanserGroup 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 cleanserGroup 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. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants at a Clinical Research Center.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin imagingNon-invasive in vivo skin imaging will be taken with the VivoSight Ox Optical Coherence Tomography (OCT). | Device | Group A: Dark Circles None, Group B: Dark Circles Mild, Group C: Dark Circles Moderate, Group D: Dark Circles Severe |
| Facial cleanserAlso: SkinMedica Facial CleanserFacial cleanser prior to procedures. | Other | Group A: Dark Circles None, Group B: Dark Circles Mild, Group C: Dark Circles Moderate, Group D: Dark Circles Severe |
Primary outcome
Dark Circles Severity Scale Score
Time frame: Day 1
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).
Classification Type of Dark Circles Score
Time frame: Day 1
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.
1 secondary outcome
Subject Questionnaire on Dark Circles, Medical History, and Lifestyle Habits
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Related InfoLink provided by the sponsor.
Related trials for Periorbital Hyperpigmentation
Active, not recruiting
Microfocused Ultrasound for Facial Pigmentary Diseases and Rosacea
Melasma, Rosacea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Goberdhan study chair
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periorbital Hyperpigmentation, run by Allergan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dark Circles Severity Scale Score (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.