Periorbital DisorderNCT03393624
Influence of Sleep Quality in Patients With Periorbicular Hyperchromia
An observational study of Periorbital Disorder, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periorbital Disorder
- How many people
- 302 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2017to 10 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Cases: Patients with periocular hyperchromia diagnosed by clinical examination.
- Controls: Patients without periocular hyperchromia diagnosed by clinical examination.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
About this study
Official title: Influence of Sleep Quality in Patients With Periorbicular Hyperchromia: a Case Control Study
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.
Read the 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
- Keywords
- Dark circles, Periorbital hyperchromia, Sleep Quality, Facial aesthetics
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 1 day visit 1
Secondary outcomes (1)
Quality of Life Index in Dermatology
To evaluate the impact of periocular hyperpigmentation on patients' dermatological quality of life comparing with patients without periocular hyperpigmentation. this is a score used to evaluate the damage caused by dermatological diseases. It consists of 10 questions, with four alternative answers, corresponding to scores from 0 to 3. The maximum score is 30 and the minimum is zero, with 30 being the highest loss in the dermatological quality of life.
Measured: at 1 day visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start1 Oct 2017
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periorbital DisorderStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliana C Boza, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393624
- Sponsor's protocol ID
- 150402
- Status last verified
- Feb 2020
- First submitted
- 3 Jan 2018
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31663247
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Sleep Quality in Patients With Periorbicular Hyperchromia: a Case Control Study
- ClinicalTrials.gov ID
- NCT03393624
- Acronym / sponsor ID
- 150402
- Conditions
- Periorbital Disorder
- Keywords
- Dark circles, Periorbital hyperchromia, Sleep Quality, Facial aesthetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Cases: Patients with periocular hyperchromia diagnosed by clinical examination.
- Controls: Patients without periocular hyperchromia diagnosed by clinical examination.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pittsburgh Sleep Quality Index
Time frame: at 1 day visit 1
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.
1 secondary outcome
Quality of Life Index in Dermatology
Time frame: at 1 day visit 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Derived from this study: PubMed 31663247Rocha 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliana C Boza, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periorbital Disorder, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (time frame: at 1 day visit 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03393624, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.