Influence of Sleep Quality in Patients With Periorbicular Hyperchromia

NCT03393624 | Completed

• 1 other identifier: 150402
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 1

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.

Conditions

Periorbital Disorder

Keywords

Dark circles; Periorbital hyperchromia; Sleep Quality; Facial aesthetics

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Quality of Life Index in Dermatology

  at 1 day visit 1

Study Arms (2)

Cases: patients with dark circles

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Related Publications (1)

• 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.

  PMID: 31663247 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Juliana C Boza, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 8, 2018
• Study Start: October 1, 2017
• Primary Completion: February 10, 2020
• Study Completion: February 10, 2020
• Last Updated: February 12, 2020

Record last verified: 2020-02

Locations

BR (1)