Influence of Sleep Quality in Patients With Periorbicular Hyperchromia

Periorbital Disorder Clinical Trial

Official title: Influence of Sleep Quality in Patients With Periorbicular Hyperchromia: a Case Control Study

Status Completed

Clinical Trial 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.

Clinical Trial 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%. ;

Related Conditions & MeSH terms

• Periorbital Disorder

• NCT number: NCT03393624
• Study type: Observational
• Source: Hospital de Clinicas de Porto Alegre
• Status: Completed
• Start date: October 1, 2017
• Completion date: February 10, 2020