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Completed

NCT Number: NCT03070288

RGB(Red- Green-Blue) Measurement of the Nasal Mucosal Image

The aim of this study was to evaluate the color values of the nasal mucosa, which is easily assessable by a direct, non-invasive, objective photographic measurement, for the purpose of presenting a diagnostic objective parameter of allergic rhinitis (AR).

All patients and controls were examined by the same 4 mm 0⁰endoscope and light source, and all endoscopic photographs of the septum and both inferior turbinates were taken. Adobe Photoshop Elements 7.0 program was used to measure the numerical values of the red-green-blue (RGB) color components in endoscopic photographs of the nasal mucosa on the septum and inferior turbinates.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

About this study

This study enrolled 73 patients with AR (Group 1) and 73 normal healthy individuals(Group 2) with no nasal pathologies and respiratory tract infection attending to the outpatient clinic of the tertiary referral center. Patient's symptoms were questioned and noted by using Lebel Symptom Score Scale. Clinical examination was also done to help diagnose and exclude acute respiratory tract infection. All of the patients had positive skin prick test results for at least one of the most common aeroallergens. All patients and controls were examined by the same 4 mm 0⁰endoscope and light source, and all endoscopic photographs of the septum and both inferior turbinates were taken. Each image was marked with standardized points at the anterior part of the nasal mucosa on both sides (2 points each right and left sides of the anterior septum and 2 points each anterior part of the inferior turbinates). These points were numbered 1 and 2 over the right inferior turbinate; 3 and 4 over the right side of the anterior septum; 4 and 5 over the left inferior turbinate; 6 and 7 over the left side of the anterior septum. Adobe Photoshop Elements 7.0 program was used to measure the numerical values of the red-green-blue color components in endoscopic photographs of the nasal mucosa on the septum and inferior turbinates.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has positive skin prick test results
  • Subject has more than 5 points of Lebel Symptom Score Scale
  • Subjects between 18-60 ages
  • Subjects with allergic rhinitis

Exclusion criteria

  • Negative skin prick test results
  • Acute respiratory tract infection existence
  • Scores less than 5 points of Lebel Symptom Score Scale

Treatment and study plan

Red-green-blue measurements of nasal mucosa image

Other

Adobe Photoshop Elements 7.0 program automatically measures the numerical values of the RGB color components in the selected area

Primary outcomes

  1. The difference of nasal mucosa color between groups

    Time frame: 3 months

    Nasal mucosa colors of the groups were measured with the numerical values of the RGB color components. All endoscopic photographs of the septum and both inferior turbinates of the patients and healthy individuals were taken while the examination at the outpatient clinic for three months. Adobe Photoshop Elements 7.0 program automatically measures the numerical values of the RGB color components in the pointed area. Color discoloration at the nasal mucosa of allergic patients compared with the healthy individuals by using RGB measurements.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

RGB(Red- Green-Blue) Measurement of the Nasal Mucosal Image: A New Diagnostic Parameter for Allergic Rhinitis

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 3, 2017
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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