Clinical trial NCT05348148: Comparison of the Effects for Lightening the Shiners Among Different Treatments for Rhinitis
Official title: Camillian Saint Mary's Hospital Luodong
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Allergic Rhinitis
Vasomotor Rhinitis
Keywords: shiners
rhinitis
Lead sponsor: Camillians Saint Mary's Hospital Luodong
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 450
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Shiners are caused when blood and other fluids accumulate in the infraorbital groove. It develops resulting from lots of problems. In patient with rhinitis, either allergic rhinitis or non-allergic rhinitis, shiners are believed to be caused by venous stasis resulting from nasal congestion. This study is aiming that comparison of the effectiveness of treatment of rhinitis (either allergic rhinitis or non-allergic rhinitis) to lighten not only the rhinitis but also the shiners. Randomized control studies.

Design: The investigators will recruit children (6-12 y/0), adolescent (13-18 y/o), or adults (19-65 y/o) with either allergic rhinitis or non-allergic rhinitis, and patients will be randomly assigned to groups (oral antihistamine, combined nasal corticosteroids with oral antihistamine, combined nasal corticosteroids with oral antihistamine plus nasal decongestant, combined nasal corticosteroids with oral antihistamine plus nasal irrigation, combined oral antihistamine with nasal irrigation, or nasal antihistamine only). Digital image will be recorded and analyzed to compare the change of shiners between before and after treatment for rhinitis. The clinical data were collected including patient's data, history, laboratory data, Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), Adolescent Rhinoconjunctivitis Quality of Life Questionnaire (AdolRQLQ), or mini Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ), and medications. The primary outcome is to answer whether the levels of shiners can be alleviated by using therapies in patient with rhinitis. And the secondary outcome is to figure out which therapies work most effectively.

Keywords: allergic rhinitis, vasomotor rhinitis, shiners, nasal corticosteroids

Detailed description: Background:

Shiners results from the accumulation of body fluid in the infraorbital groove. The physiology and pathology in children include nasal congestion, inﬂammation of nose and eyes, trauma to the nose or the forehead, facial surgery, or facial cancer. In patient with either allergic rhinitis or non-allergic rhinitis, nasal congestion arouses venous stasis, leading to the blue-gray to purple discoloration under the bilateral lower eyelids, called shiners. In patients with allergic rhinitis, allergic shiners, termed by Marks since 1954, have been regarded as a significant sign of allergic rhinitis generally.

In 2009, Chiang and members established a digital-analyzed tool to quantify allergic shiners, and the results demonstrated the darkness and the area values of allergic shiners correlate with the severity of allergic rhinitis.

A stepwise approach for the treatment of allergic rhinitis and non-allergic rhinitis is documented, including oral antihistamine, intranasal antihistamine, intranasal corticosteroids, intranasal decongestant, oral or intranasal leukotriene antagonist, as well as nasal irrigation, but the response of shiners after treatment, and the efficiency of the therapies to alleviate the shiners were unknown. In this study, the primary outcome is to answer whether the levels of shiners can be alleviated by using nasal therapies in patients with allergic rhinitis or non-allergic rhinitis. And the secondary outcome is to figure out which nasal therapies work most effectively.

Design:

The investigators will recruit children (6-12 years old), adolescent (13-18 years old), and adults (19-65 years old) with moderate to severe rhinitis, either allergic rhinitis or non-allergic rhinitis. Those with chronic rhinosinusitis, trauma to the forehead or nose, face surgery, malignancy, pregnancy, and respiratory tract infections or usage of medications for rhinitis within a week before beginning the study will be excluded. Study population will be classified into children, adolescent and adults according to the age.

This study will be divided into three stages. In the first stage, three kinds of therapies for rhinitis were compared. Patients will be randomly assigned into three groups. Patients in group 1 will use oral antihistamine only, another in group 2 will use combined intranasal corticosteroids with oral antihistamine, and the other in group 3 will use combined intranasal corticosteroids with oral antihistamine plus one-week intranasal decongestant. In the second stage, three kinds of therapies will be compared, including combined intranasal corticosteroids and oral antihistamine, combined intranasal corticosteroids and oral antihistamine plus nasal irrigation, and oral antihistamine plus nasal irrigation. The third stage will compare oral antihistamine only, combined intranasal corticosteroids with oral antihistamine, and intranasal antihistamine. The estimated sample size was 50 cases in each groups, and total 150 cases in each population and total 450 cases in each stage. Patients will be randomized by a randomization table. Minimization will be performed when over 100 cases in each population and in each stage.

A standardized digital photograph of every participant will be recorded and further analyzed to compare the change of shiners between before and after treatment for rhinitis. The clinical data will be collected including patient's data, history, laboratory data, Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) of every children, Adolescent Rhinoconjunctivitis Quality of Life Questionnaire (AdolRQLQ) of every adolescent, or mini Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ) of every adult, and medications.

Digital images and the questionnaires, including PRQLQ, AdolRQLQ, and mini-RQLQ, of every participant will be taken at the beginning of the study. Further assessments will be taken at least 3 times, on the seventh day, fourteenth day, and twenty-eighth day after treatment.

The detail method to take a standardized digital photography, and analyze digital image were described in the previous study. Briefly, in order to standardize both the size and color of the photographs, a color checker used as a reference was set in front of the every participant's chin. Pixel, the elemental unit of digital image, was calculated in each photographs. After completing preprocess in every digital sample, the investigators converted the intensity value of each pixel into the gray level, then measured the gray-level mean values in the infraorbital groove (Sm) and cheek (Cm), respectively. Darkness (D) was equal to Cm-Sm. The blacker a shiner appeared, the bigger the darkness value was. Shiner's area value was figured out by sampling the curve of each lower eyes. The investigators translated the value from pixels to square centimeters, and finally normalized by body surface area to gain the parameter A (in square centimeters per square meter) represented as the area value of shiner.

The independent researchers will carry out the digital image analyze.

The primary outcome is to answer whether the levels of shiners can be alleviated by using therapies in patient with rhinitis. And the secondary outcome is to figure out which therapies work most effectively.

Statistical analysis The investigators compared the categorical variables between the two groups using the Pearson's Chi square test. The investigators compared the continuous variables between the two groups using Mann-Whitney U test. The correlation between two parameters was analyzed by Pearson correlation test. The investigators used paired samples t-test and/or multiple regression analysis to what kind of treatment was more effective to alleviate the shiners with/without improvement of rhinitis. To account for correlation among repeated measures from the same patient, the study was analyzed with the usage of linear generalized estimating equations. A p value \< 0.05 was considered statistically significant. All statistical analyses were performed with International Business Machines Corporation Statistical Product and Service Solutions statistical software (version 20.0.0, IBM Corp., Armonk, NY).

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of moderate to severe rhinitis, either allergic rhinitis or non-allergic rhinitis.

Exclusion Criteria:

* Chronic rhinosinusitis
* Trauma to the forehead or nose
* Face surgery
* Malignancy
* Pregnancy
* Respiratory tract infections within a week before beginning the study
* Usage of medications for rhinitis within a week before beginning the study

Primary outcomes:
measure: alleviating darkness of shiners
timeFrame: Change from baseline darkness of shiners at 1 week after treatment.
measure: alleviating darkness of shiners
timeFrame: Change from baseline darkness of shiners at 2 weeks after treatment.
measure: alleviating darkness of shiners
timeFrame: Change from baseline darkness of shiners at 4 weeks after treatment.
measure: alleviating area value of shiners
timeFrame: Change from baseline area value of shiners at 1 week after treatment.
measure: alleviating area value of shiners
timeFrame: Change from baseline area value of shiners at 2 week after treatment.
measure: alleviating area value of shiners
timeFrame: Change from baseline area value of shiners at 4 week after treatment.
Secondary outcomes:
measure: alleviating darkness of shiners among groups
timeFrame: Change from baseline darkness of shiners at 1 week after treatment.
measure: alleviating darkness of shiners among groups
timeFrame: Change from baseline darkness of shiners at 2 week after treatment.
measure: alleviating darkness of shiners among groups
timeFrame: Change from baseline darkness of shiners at 4 week after treatment.
measure: alleviating area value of shiners among groups
timeFrame: Change from baseline area value of shiners at 1 week after treatment.
measure: alleviating area value of shiners among groups
timeFrame: Change from baseline area value of shiners at 2 week after treatment.
measure: alleviating area value of shiners among groups
timeFrame: Change from baseline area value of shiners at 4 week after treatment.
Other outcomes:
Locations:
city: Luodong
country: Taiwan
facility: Camillian Saint Mary's Hospital Luodong
state: Yilan
Study officials:
affiliation: Camillian Saint Mary's Hospital Luodong
name: Cheng-Tsung Yang
role: PRINCIPAL_INVESTIGATOR
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