Nasal ObstructionEarly Phase 1NCT05142072
Design and Application of Vitamin D Films for Burn Healing After Cauterizing Surgery
A Early Phase 1 study testing Vitamin D3 in people with Nasal Obstruction, run by Deraya University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Obstruction
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Dec 2021to 20 Feb 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients complain of nasal obstruction
- do not respond to medications
- treatment need surgery
- patients accept following up in a timely manner for 3 weeks
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Minya university, faculty of medicin
Minya, Minya Governorate, 05673
About this study
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
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.
- Conditions
- Nasal Obstruction
- Being tested
- Vitamin D3
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called Calciferol
intranasal film
| Study group | Role | What they receive |
|---|---|---|
| vitamin D film | Experimental | Prepared intranasal films containing vitamin D3 by the investigators and administered to the right nostril with the aid of an ENT surgeon Receives: Drug: Vitamin D3 |
| control group | Other | No devices will be added Receives: Drug: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three week
Secondary outcomes (2)
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
Measured: three weeks
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)
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start18 Dec 2021
- Primary completion18 Jan 2022
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soad Ali, Deraya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142072
- Sponsor's protocol ID
- DNFs
- Other IDs
- Ahmed Ali
- Status last verified
- Mar 2022
- First submitted
- 25 Oct 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05142072
- Acronym / sponsor ID
- DNFs
- Conditions
- Nasal Obstruction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 18 Dec 2021 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D film | Experimental | Drug: Vitamin D3Prepared intranasal films containing vitamin D3 by the investigators and administered to the right nostril with the aid of an ENT surgeon |
| control group | Other | Drug: Vitamin D3No devices will be added |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients complain of nasal obstruction
- do not respond to medications
- treatment need surgery
- patients accept following up in a timely manner for 3 weeks
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Also: Calciferolintranasal film | Drug | control group, vitamin D film |
Primary outcome
Healing of cauterized tissues after surgery procedures
Time frame: 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.
2 secondary outcomes
patients compliance from the new dosage form
Time frame: three weeks
Assessment of grades of healing by ENT surgeon
Time frame: three weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vitamin D3 in people with Nasal Obstruction, run by Deraya University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing of cauterized tissues after surgery procedures (time frame: three week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.