NCT03393624|Completed
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Sponsor study identifier
observational
302
1 country
1
Study Start
October 1, 2017
Actual (reported)Primary Completion
February 10, 2020
Actual (reported)Study Completion
February 10, 2020
Actual (reported)Periorbital hyperchromia (POH) or periorbital hyperpigmentation, commonly known as "dark circles", is a relatively common condition and a frequent reason for dermatological consultation. It is defined as brown-colored pigmentation, ranging from light to dark, which mainly involves the lower eyelids. POH affects individuals over a wide age range, including both sexes and all ethnicities, and is associated with a tired and aged facial appearance. The most commonly affected people are those with the highest skin phototypes. Although the prevalence is similar between sexes and age groups, POH is a more frequent complaint in women. The dark circles characteristic of POH can negatively impact patients' quality of life, although it is not a condition associated with morbidity. Popularly it is believed that the poor quality of sleep is a factor responsible for its appearance, but there is no consistent data in the literature that prove this.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 10, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2017
Actual (reported)January 3, 2018
Actual (reported)January 8, 2018
Actual (reported)February 10, 2020
Actual (reported)February 10, 2020
Actual (reported)Pittsburgh Sleep Quality Index
To evaluate the sleep quality in patients with periocular hyperpigmentation comparing with patients without periocular hyperpigmentation. The questionnaire consists of 19 questions, which are grouped into 7 components, with values distributed on a scale of zero to 3. These components are subjective quality of sleep, sleep latency, sleep duration, habitual sleep efficiency , sleep disorders, use of sleeping pills, and daytime dysfunction. The scores of these components are summed to form a global score, ranging from zero to 21. The higher the score, the worse the quality of sleep. A PSQI score\> 5 indicates that the individual is experiencing major difficulties in at least 2 components, or moderate difficulties in more than 3 components.
at 1 day visit 1
Quality of Life Index in Dermatology
at 1 day visit 1
Patients who believe they have periorbicular hyperchromia and have a confirmatory physical examination performed by a dermatologist.
Patients who believe that they do not have periorbicular hyperchromia under their eyes and have physical examination that excludes dark circles carried out by a dermatologist.
Men and women over 18 years of age who agree to answer to quality of sleep and quality of life questionnaires. The "case" group should present periorbicular hyperchromia confirmed by physical examination and the group called "control" should not present periorbicular hyperchromia excluded by physical examination.
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Rocha Barone C, Catucci Boza J, Challub Pires G, Perusato Pereira P, Ferreira Cestari T. The influence of sleep quality on the development of periocular hyperchromia: a case-control study. J Cosmet Dermatol. 2020 Jul;19(7):1760-1767. doi: 10.1111/jocd.13195. Epub 2019 Oct 30.
Juliana C Boza, PhD
Hospital de Clinicas de Porto Alegre
302 participants (actual enrollment reported by the registry).
First Submitted
January 3, 2018
First Posted
January 8, 2018
Study Start
October 1, 2017
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
February 10, 2020
Actual (reported)Study Completion
February 10, 2020
Actual (reported)Last Updated
February 12, 2020
Record last verified: 2020-02
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Source: ClinicalTrials.gov.
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