Comparison of the Effects for Lightening the Shiners Among Different Treatments for Rhinitis

Sponsor

Camillians Saint Mary's Hospital Luodong (Other)

Overall Status

Recruiting

CT.gov ID

NCT05348148

Collaborator

(none)

450

Enrollment

Location

Arms

141.5

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis Vasomotor Rhinitis	Drug: Oral Levocetirizine Drug: Combined Intranasal Mometasone Furoate with oral Levocetirizine Drug: Combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

The independent researchers will carry out the digital image analyze.

Primary Purpose:

Treatment

Official Title:

Camillian Saint Mary's Hospital Luodong

Actual Study Start Date :

Jun 16, 2020

Anticipated Primary Completion Date :

Mar 31, 2032

Anticipated Study Completion Date :

Mar 31, 2032

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Oral Levocetirizine Patients in Levocetirizine group will use oral antihistamine (Levocetirizine) only	Drug: Oral Levocetirizine Patients will be randomly assigned into three groups. Patients in oral Levocetirizine group will use oral antihistamine only (Levocetirizine), another in combined Intranasal Mometasone Furoate with oral Levocetirizine group will use combined intranasal corticosteroids (intranasal Mometasone Furoate) with oral antihistamine (Levocetirizine), and the other in combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline group will use combined intranasal corticosteroids (intranasal Mometasone Furoate) with oral antihistamine (Levocetirizine) plus one-week intranasal decongestant (intranasal Oxymetazoline). 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.
Active Comparator: Combined Intranasal Mometasone Furoate with oral Levocetirizine Patients in combined Intranasal Mometasone Furoate with oral Levocetirizineintranasal group will use combined intranasal corticosteroids (intranasal Mometasone Furoate) with oral antihistamine (Levocetirizine)	Drug: Combined Intranasal Mometasone Furoate with oral Levocetirizine Patients will be randomly assigned into three groups. Patients in oral Levocetirizine group will use oral antihistamine only (Levocetirizine), another in combined Intranasal Mometasone Furoate with oral Levocetirizine group will use combined intranasal corticosteroids (intranasal Mometasone Furoate) with oral antihistamine (Levocetirizine), and the other in combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline group will use combined intranasal corticosteroids (intranasal Mometasone Furoate) with oral antihistamine (Levocetirizine) plus one-week intranasal decongestant (intranasal Oxymetazoline). 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.
Active Comparator: Combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline The other in combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline group will use combined intranasal corticosteroids (intranasal Mometasone Furoate) with oral antihistamine (Levocetirizine) plus one-week intranasal decongestant (intranasal Oxymetazoline)	Drug: Combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline Patients will be randomly assigned into three groups. Patients in oral Levocetirizine group will use oral antihistamine only (Levocetirizine), another in combined Intranasal Mometasone Furoate with oral Levocetirizine group will use combined intranasal corticosteroids (intranasal Mometasone Furoate) with oral antihistamine (Levocetirizine), and the other in combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline group will use combined intranasal corticosteroids (intranasal Mometasone Furoate) with oral antihistamine (Levocetirizine) plus one-week intranasal decongestant (intranasal Oxymetazoline). 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.

Arm

Intervention/Treatment

Active Comparator: Oral Levocetirizine

Patients in Levocetirizine group will use oral antihistamine (Levocetirizine) only

Drug: Oral Levocetirizine

Patients will be randomly assigned into three groups. Patients in oral Levocetirizine group will use oral antihistamine only (Levocetirizine), another in combined Intranasal Mometasone Furoate with oral Levocetirizine group will use combined intranasal corticosteroids (intranasal Mometasone Furoate) with oral antihistamine (Levocetirizine), and the other in combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline group will use combined intranasal corticosteroids (intranasal Mometasone Furoate) with oral antihistamine (Levocetirizine) plus one-week intranasal decongestant (intranasal Oxymetazoline). 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.

Active Comparator: Combined Intranasal Mometasone Furoate with oral Levocetirizine

Patients in combined Intranasal Mometasone Furoate with oral Levocetirizineintranasal group will use combined intranasal corticosteroids (intranasal Mometasone Furoate) with oral antihistamine (Levocetirizine)

Drug: Combined Intranasal Mometasone Furoate with oral Levocetirizine

Active Comparator: Combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline

The other in combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline group will use combined intranasal corticosteroids (intranasal Mometasone Furoate) with oral antihistamine (Levocetirizine) plus one-week intranasal decongestant (intranasal Oxymetazoline)

Drug: Combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline

Outcome Measures

Primary Outcome Measures

alleviating darkness of shiners [Change from baseline darkness of shiners at 1 week after treatment.]
Change from baseline of the darkness of shiners at 1 week after treatment.
alleviating darkness of shiners [Change from baseline darkness of shiners at 2 weeks after treatment.]
Change from baseline of the darkness of shiners at 2 week after treatment.
alleviating darkness of shiners [Change from baseline darkness of shiners at 4 weeks after treatment.]
Change from baseline of the darkness of shiners at 4 week after treatment.
alleviating area value of shiners [Change from baseline area value of shiners at 1 week after treatment.]
Change from baseline of the area value of shiners at 1 week after treatment.
alleviating area value of shiners [Change from baseline area value of shiners at 2 week after treatment.]
Change from baseline of the area value of shiners at 2 week after treatment.
alleviating area value of shiners [Change from baseline area value of shiners at 4 week after treatment.]
Change from baseline of the area value of shiners at 4 week after treatment.

Secondary Outcome Measures

alleviating darkness of shiners among groups [Change from baseline darkness of shiners at 1 week after treatment.]
Change from baseline of the darkness of shiners at 1 week after treatment among groups (including oral Levocetirizine group, combined Intranasal Mometasone Furoate with oral Levocetirizine group, and combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline group).
alleviating darkness of shiners among groups [Change from baseline darkness of shiners at 2 week after treatment.]
Change from baseline of the darkness of shiners at 2 week after treatment among groups (including oral Levocetirizine group, combined Intranasal Mometasone Furoate with oral Levocetirizine group, and combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline group).
alleviating darkness of shiners among groups [Change from baseline darkness of shiners at 4 week after treatment.]
Change from baseline of the darkness of shiners at 4 week after treatment among groups (including oral Levocetirizine group, combined Intranasal Mometasone Furoate with oral Levocetirizine group, and combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline group).
alleviating area value of shiners among groups [Change from baseline area value of shiners at 1 week after treatment.]
Change from baseline of the area value of shiners at 1 week after treatment among groups (including oral Levocetirizine group, combined Intranasal Mometasone Furoate with oral Levocetirizine group, and combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline group).
alleviating area value of shiners among groups [Change from baseline area value of shiners at 2 week after treatment.]
Change from baseline of the area value of shiners at 2 week after treatment among groups (including oral Levocetirizine group, combined Intranasal Mometasone Furoate with oral Levocetirizine group, and combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline group).
alleviating area value of shiners among groups [Change from baseline area value of shiners at 4 week after treatment.]
Change from baseline of the area value of shiners at 4 week after treatment among groups (including oral Levocetirizine group, combined Intranasal Mometasone Furoate with oral Levocetirizine group, and combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline group).