Influence of Sleep Quality in Patients With Periorbicular Hyperchromia

NCT ID: NCT03393624

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 302 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2020-02-10

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%.

Conditions

Periorbital Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Cases: patients with dark circles

Patients who believe they have periorbicular hyperchromia and have a confirmatory physical examination performed by a dermatologist.

No interventions assigned to this group

Controls: patients without dark circles

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juliana C Boza, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 31663247 (View on PubMed)

Other Identifiers

150402

Identifier Type: -

Identifier Source: org_study_id