NCT05348148

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
72mo left

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Jun 2020Mar 2032

Study Start

First participant enrolled

June 16, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2032

Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

11.8 years

First QC Date

December 22, 2021

Last Update Submit

April 20, 2022

Conditions

Allergic RhinitisVasomotor Rhinitis

Keywords

shinersrhinitis

Outcome Measures

Primary Outcomes (6)

  • alleviating darkness of shiners

    Change from baseline of the darkness of shiners at 1 week after treatment.

    Change from baseline darkness of shiners at 1 week after treatment.

  • alleviating darkness of shiners

    Change from baseline of the darkness of shiners at 2 week after treatment.

    Change from baseline darkness of shiners at 2 weeks after treatment.

  • alleviating darkness of shiners

    Change from baseline of the darkness of shiners at 4 week after treatment.

    Change from baseline darkness of shiners at 4 weeks after treatment.

  • alleviating area value of shiners

    Change from baseline of the area value of shiners at 1 week after treatment.

    Change from baseline area value of shiners at 1 week after treatment.

  • alleviating area value of shiners

    Change from baseline of the area value of shiners at 2 week after treatment.

    Change from baseline area value of shiners at 2 week after treatment.

  • alleviating area value of shiners

    Change from baseline of the area value of shiners at 4 week after treatment.

    Change from baseline area value of shiners at 4 week after treatment.

Secondary Outcomes (6)

  • alleviating darkness of shiners among groups

    Change from baseline darkness of shiners at 1 week after treatment.

  • alleviating darkness of shiners among groups

    Change from baseline darkness of shiners at 2 week after treatment.

  • alleviating darkness of shiners among groups

    Change from baseline darkness of shiners at 4 week after treatment.

  • alleviating area value of shiners among groups

    Change from baseline area value of shiners at 1 week after treatment.

  • alleviating area value of shiners among groups

    Change from baseline area value of shiners at 2 week after treatment.

  • +1 more secondary outcomes

Study Arms (3)

Oral Levocetirizine

ACTIVE COMPARATOR

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

Drug: Oral Levocetirizine

Combined Intranasal Mometasone Furoate with oral Levocetirizine

ACTIVE COMPARATOR

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

Combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline

ACTIVE COMPARATOR

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

Interventions

Oral LevocetirizineDRUG

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.

Oral Levocetirizine
Combined Intranasal Mometasone Furoate with oral LevocetirizineDRUG

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.

Combined Intranasal Mometasone Furoate with oral Levocetirizine
Combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal OxymetazolineDRUG

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.

Combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline

Eligibility Criteria

Age6 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Camillian Saint Mary's Hospital Luodong

Luodong, Yilan, 26546, Taiwan

RECRUITING

Related Publications (25)

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  • MARKS MB. Nasal allergy in childhood. Observations in the South Florida area. Ann Allergy. 1960 Oct;18:1110-6. No abstract available.

    PMID: 13766957RESULT

  • Marks MB. Significance of discoloration in the lower orbitopalpebral grooves in allergic children (allergic shiners). Ann Allergy 1963;21:26-32.

    RESULT

  • Berger WE. Allergic rhinitis in children : diagnosis and management strategies. Paediatr Drugs. 2004;6(4):233-50. doi: 10.2165/00148581-200406040-00003.

    PMID: 15339201RESULT

  • Quillen DM, Feller DB. Diagnosing rhinitis: allergic vs. nonallergic. Am Fam Physician. 2006 May 1;73(9):1583-90.

    PMID: 16719251RESULT

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    PMID: 16490466RESULT

  • Chen CH, Lin YT, Wen CY, Wang LC, Lin KH, Chiu SH, Yang YH, Lee JH, Chiang BL. Quantitative assessment of allergic shiners in children with allergic rhinitis. J Allergy Clin Immunol. 2009 Mar;123(3):665-71, 671.e1-6. doi: 10.1016/j.jaci.2008.12.1108.

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    PMID: 11707753RESULT

  • Sur DKC, Plesa ML. Chronic Nonallergic Rhinitis. Am Fam Physician. 2018 Aug 1;98(3):171-176.

    PMID: 30215894RESULT

  • Scadding GK, Kariyawasam HH, Scadding G, Mirakian R, Buckley RJ, Dixon T, Durham SR, Farooque S, Jones N, Leech S, Nasser SM, Powell R, Roberts G, Rotiroti G, Simpson A, Smith H, Clark AT. BSACI guideline for the diagnosis and management of allergic and non-allergic rhinitis (Revised Edition 2017; First edition 2007). Clin Exp Allergy. 2017 Jul;47(7):856-889. doi: 10.1111/cea.12953.

    PMID: 30239057RESULT

  • Agnihotri NT, McGrath KG. Allergic and nonallergic rhinitis. Allergy Asthma Proc. 2019 Nov 1;40(6):376-379. doi: 10.2500/aap.2019.40.4251.

    PMID: 31690374RESULT

  • Wise SK, Lin SY, Toskala E, Orlandi RR, Akdis CA, Alt JA, Azar A, Baroody FM, Bachert C, Canonica GW, Chacko T, Cingi C, Ciprandi G, Corey J, Cox LS, Creticos PS, Custovic A, Damask C, DeConde A, DelGaudio JM, Ebert CS, Eloy JA, Flanagan CE, Fokkens WJ, Franzese C, Gosepath J, Halderman A, Hamilton RG, Hoffman HJ, Hohlfeld JM, Houser SM, Hwang PH, Incorvaia C, Jarvis D, Khalid AN, Kilpelainen M, Kingdom TT, Krouse H, Larenas-Linnemann D, Laury AM, Lee SE, Levy JM, Luong AU, Marple BF, McCoul ED, McMains KC, Melen E, Mims JW, Moscato G, Mullol J, Nelson HS, Patadia M, Pawankar R, Pfaar O, Platt MP, Reisacher W, Rondon C, Rudmik L, Ryan M, Sastre J, Schlosser RJ, Settipane RA, Sharma HP, Sheikh A, Smith TL, Tantilipikorn P, Tversky JR, Veling MC, Wang Y, Westman M, Wickman M, Zacharek M. International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis. Int Forum Allergy Rhinol. 2018 Feb;8(2):108-352. doi: 10.1002/alr.22073.

    PMID: 29438602RESULT

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    PMID: 25629743RESULT

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MeSH Terms

Conditions

Rhinitis, AllergicRhinitis, VasomotorRhinitis

Interventions

levocetirizine

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiratory Tract InfectionsInfections

Study Officials

  • Cheng-Tsung Yang

    Camillian Saint Mary's Hospital Luodong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng-Tsung Yang

CONTACT

886+926436056jjbulebeer@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The independent researchers will carry out the digital image analyze.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2021

First Posted

April 27, 2022

Study Start

June 16, 2020

Primary Completion (Estimated)

March 31, 2032

Study Completion (Estimated)

March 31, 2032

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)