Design and Application of Vitamin D Films for Burn Healing After Cauterizing Surgery

Nasal Obstruction Clinical Trial

Official title:

Formulation, Characterization and In-vivo Evaluation of Controlled Release Intranasal Films of Vitamin D3 as an Optimistic Dosage Form for Rapid and Effective Healing of Cauterized Turbinectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05142072
• Other study ID #: DNFs
• Secondary ID: Ahmed Ali
• Status: Completed
• Phase: Early Phase 1
• Start date: December 18, 2021
• Est. completion date: February 20, 2022

Study information

• Verified date: March 2022
• Source: Deraya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

One of this method's drawbacks is the healing of cauterized cartilage after processing. It was reported that the healing is so slow as no dosage form can reach this place in addition to the scares produced from healing is very irritable to the patient.

From this point, the investigators start searching for a solution to this problem and reach the repositioning of Vitamin D3 (calciferol) as an active ingredient for the rapidity and efficacy of burn healing.

The dosage form of choice that was reported before for intranasal application by the same team of investigators and gave good results. the intranasal films were proved for its convince, simplicity, efficacy, and compliance to patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 20, 2022
• Est. primary completion date: January 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• patients complain of nasal obstruction

• do not respond to medications

• treatment need surgery

• patients accept following up in a timely manner for 3 weeks

Exclusion Criteria:

• no nasal polyps,

• have problems with the surgical procedures

• have allergy with any of the treatment components (vitamin D3 or chitosan)

• don't follow instructions or miss the following up

Related Conditions & MeSH terms

• Nasal Obstruction

Intervention

Drug:
• Vitamin D3
intranasal film

Locations

Country	Name	City	State
Egypt	Minya university, faculty of medicin	Minya	??????

Sponsors (1)

Lead Sponsor	Collaborator
Deraya University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing of cauterized tissues after surgery procedures	The outcome will be measured by endoscopic scanning pre and after application of the drug in the dosage form (representing the percent of healing) by the ENT surgeon.	three week
Secondary	patients compliance from the new dosage form	The patient compliance will be measured by rating the pain and the development of symptoms before surgery using a questionnaire	three weeks
Secondary	Assessment of grades of healing by ENT surgeon	Evaluation of (1) bleeding (amount and frequencies), (2) crustation ( amount and nature), and (3) inflammation (size and the redness of the place of surgery)	three weeks