Preparation and clinical evaluation of a novel colchicine mucoadhesive gel for the treatment of aphthous stomatitis

Phase 3

Recruiting

• Conditions: Aphthous stomatitis.

• Registration Number: IRCT20191106045356N8
• Lead Sponsor: Yazd University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients with aphthous stomatitis starting up to two days
Patient between 18-65 years old
No pregnancy and lactation
No history of allergies to colchicine

Exclusion Criteria

Patients with skin diseases
Sensitivity to colchicine or any of the components of the product
Do not use the drug for two consecutive days
Exacerbation of the aphthous stomatitis

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of pain. Timepoint: At the beginning of treatment and after every 2 to 10 days, the condition of aphthous lesions is evaluated for pain intensity (score 0 to 4). Method of measurement: Scoring pain using a questionnaire.;Redness and inflammation. Timepoint: At the beginning of treatment and after every 2 to 10 days, the condition of aphthous lesions is evaluated for the severity of redness and inflammation (score 0 to 4). Method of measurement: Scoring severe redness and inflammation using a questionnaire.;Total area of ??aphthous lesions. Timepoint: At the beginning of treatment and after every 2 to 10 days, the condition of the aphthous lesions is evaluated in terms of the total area of ??the aphthous lesions. Method of measurement: Determining the total area of ??aphthous lesions through Fiji software.