Clinical trial NCT03393624: Influence of Sleep Quality in Patients With Periorbicular Hyperchromia
Official title: Influence of Sleep Quality in Patients With Periorbicular Hyperchromia: a Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periorbital Disorder
Keywords: Dark circles
Periorbital hyperchromia
Sleep Quality
Facial aesthetics
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: We aim to compare the quality of sleep through the Pittsburgh Sleep Quality Index (PSQI-BR) already translated and validated in Portuguese for patients with periorbicular hyperchromia (cases) with patients without this complaint (controls) and to compare dermatological quality of life through the Quality of Life in Dermatology Index (DLQI) already translated and validated for Portuguese patients with periorbicular hyperchromia (cases) with patients without this complaint (controls). Patients and / or family members who consult in the Dermatology of the Hospital de Clínicas of Porto Alegre (preferably), but also other patients and / or relatives with outpatient care in this institution will be invited to participate in the control group.

The WinPepi program, version 11.32, was used to calculate the sample size. This objective predicts a Pareto Control Case study by age, with a ratio of 1: 1. The sample size was 252 subjects, 126 cases and 126 controls. Adding 10% to possible losses and refusals the sample size should be 280 subjects, with 140 cases and 140 controls. This value was stipulated taking into account the mean of 5.9 in the PSQI-BR of the cases already collected (n = 148 subjects) and corresponds to a difference of almost 3 points in the index ranging from zero to 21, corresponding to approximately 15% difference between groups. For this calculation was considered 80% power and significance level of 5%.

Eligibility criteria: Inclusion Criteria:

* Cases: Patients with periocular hyperchromia diagnosed by clinical examination.
* Controls: Patients without periocular hyperchromia diagnosed by clinical examination.

Exclusion Criteria:

* Pregnant patients
* Active collagenase patients
* Patients with bacterial or viral infections on the periorbicular area
* Patients undergoing any treatment modality for periocular hyperpigmentation in the last 3 months.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: at 1 day visit 1
Secondary outcomes:
measure: Quality of Life Index in Dermatology
timeFrame: at 1 day visit 1
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Juliana C Boza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.