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

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05142072

Enrollment

Registered

2021-12-02

Start date

2021-12-18

Completion date

2022-02-20

Last updated

2022-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Obstruction

Brief 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.

Interventions

DRUGVitamin D3

intranasal film

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Healing of cauterized tissues after surgery procedures	three week	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.

Secondary

Measure	Time frame	Description
patients compliance from the new dosage form	three weeks	The patient compliance will be measured by rating the pain and the development of symptoms before surgery using a questionnaire
Assessment of grades of healing by ENT surgeon	three weeks	Evaluation of (1) bleeding (amount and frequencies), (2) crustation ( amount and nature), and (3) inflammation (size and the redness of the place of surgery)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026