Drug EffectPhase 1NCT03615820
Niosomal Propolis as Oromucoadhesive Film: In-vitro, Ex-vivo & In-vivo Investigations
A Phase 1 study testing Niosomal PPE oromucoadhesive film and Oromucoadhesive film in people with Drug Effect and Drug Effect Prolonged, run by British University In Egypt at 2 sites in Egypt.
Trial summary
A total of 24 patients suffering from RAU, they were divided into two groups each included 12 patients. The first group was treated by the propolis mucoadhesive film and the second group received the film without the active component (placebo group).Patients were handed a checklist for monitoring the actual… Read more about this study
- Who is it for?
- Ages 40 to 45 years
- Conditions the study is for
- Drug Effect, Drug Effect Prolonged
- What is being tested?
- Niosomal PPE oromucoadhesive film and Oromucoadhesive film
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2018to 30 Jan 2018
- Phase
- 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 40 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients suffer from aphthous ulcer
Who cannot join
- Chronic diseases ,
- Hospitalized
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Mona G Arafa
Cairo, 11837
Mona G Arafa
New Cairo, Cairo Governorate, 11837
About this study
Official title: Propolis-based Nanovesicles as Oromuco-adhesive Film: Novel Therapeutic Drug Delivery System for Treatment of Oral Recurrent Aphthous Ulcer
A total of 24 patients suffering from RAU, they were divided into two groups each included 12 patients. The first group was treated by the propolis mucoadhesive film and the second group received the film without the active component (placebo group).Patients were handed a checklist for monitoring the actual improvement of the clinical parameters which included; duration of disappearance of pain after film application (hours), duration of complete healing of the aphthous ulcer (weeks), onset of ulcer size reduction after film application (days), duration of propolis film adherence onto the oral mucosa (hours) and finally the level of patient satisfaction scaled from 1-10.
Read the detailed description
The present study have been performed on a total of 24 patients suffering from RAU, they were divided into two groups each included 12 patients. The first group was treated by the propolis mucoadhesive film and the second group received the film without the active component (placebo group). Patients were recruited from the out-patient clinic of the Faculty of Dentistry, British University in Egypt during a period of 6 months.
Patients were subjected to thorough clinical examination and history obtaining in order to diagnose the oral ulcer by an oral medicine specialist, they were thoroughly informed about the study and only those with the oral ulcer within the first day to the third day of appearance were included in the present study.
The exclusion criteria in the present study were the presence of systemic or local disease such as hepatitis, cardiac conditions, hypertension, diabetes mellitus, renal problems, mental disorders, AIDS and also the use of any immunosuppressive drugs or systemic corticosteroids during last three months or using steroid treatment locally in last month, also any nutritional supplements, folic acid or antioxidants, pregnancy and nursing.
All patients were asked to avoid using antiseptics, antibiotics or analgesics, during the study as they might aid in curing the oral ulcers. Patients were blinded of receiving either propolis or placebo. They were warned about the potentiality of allergic responses that could happen to some people and that in case of occurrence of such side effect immediate termination of using the film should be implemented.
The patients were first instructed how to apply the mucoadhesive film of 2 cm2 on the oral ulcer and pasted by applying a light force with the finger tip for 20 s, and then were asked to apply it two times per day and to refrain from eating for at least one hour after the film application on the oral ulcer.
Patients were handed a checklist for monitoring the actual improvement of the clinical parameters which included; duration of disappearance of pain after film application (hours), duration of complete healing of the aphthous ulcer (weeks), onset of ulcer size reduction after film application (days), duration of propolis film adherence onto the oral mucosa (hours) and finally the level of patient satisfaction scaled from 1-10. After total healing of the oral RAU, checklists were recollected from patients, the results were tabulated and statistical analysis were conducted.
- Conditions
- Drug Effect, Drug Effect Prolonged
- Being tested
- Niosomal PPE oromucoadhesive film, Oromucoadhesive film
- Keywords
- Nanovesicles, Aphthous ulcer
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niosomal PPE oromucoadhesive filmDrug
Niosomal PPE oromucoadhesive film in which Propolis entrapped in niosomal vesicles and incorporated in oromucoadhesive film
Oromucoadhesive filmDrug
Oromucoadhesive film without PPE control testing which represents Placebo group
| Study group | Role | What they receive |
|---|---|---|
| Niosomal PPE oromucoadhesive film | Experimental | Niosomal PPE oromucoadhesive film in which PPE entrapped in niosomes then incorporated in oromucoadhesive films Receives: Drug: Niosomal PPE oromucoadhesive film; Drug: Oromucoadhesive film |
| Oromucoadhesive film | Placebo comparator | Oromucoadhesive film that has no niosomal PPE in its content Receives: Drug: Niosomal PPE oromucoadhesive film; Drug: Oromucoadhesive film |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the onset of ulcer size reduction
Niosomal PPE in oromuco-adhesive film was prepared \& given to 12 patients to examine the onset of ulcer size reduction The patients were first instructed how to apply the mucoadhesive film of 2 cm2 on the oral ulcer and then they were handed a checklist for monitoring the actual improvement that was indicated by the reduction of the size of ulcer.
Measured: Fifteen Days
Secondary outcomes (1)
Duration of complete ulcer healing
oromuco-adhesive film was prepared \& given to 12 patients to examine the duration of complete healing.The patients were first instructed how to apply the mucoadhesive film of 2 cm2 on the oral ulcer and then they were handed a checklist for monitoring the actual improvement that was indicated by the complete healing of ulcer.
Measured: Fifteen Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Jan 2018
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug EffectStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Volunteers will be divided into two groups; each group contained 12 volunteers who will receive one formula of the selected formulae
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Gamal Mohamed Afifi Arafa, British University In Egypt
- Investigators
- Mona G Arafa, PhD, Principal investigator, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615820
- Sponsor's protocol ID
- PPEADHNIO-2018-4
- Status last verified
- Jul 2018
- First submitted
- 30 Mar 2018
- Last updated
- 6 Aug 2018
- 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 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propolis-based Nanovesicles as Oromuco-adhesive Film: Novel Therapeutic Drug Delivery System for Treatment of Oral Recurrent Aphthous Ulcer
- ClinicalTrials.gov ID
- NCT03615820
- Acronym / sponsor ID
- PPEADHNIO-2018-4
- Conditions
- Drug Effect, Drug Effect Prolonged
- Keywords
- Nanovesicles, Aphthous ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 6 Aug 2018 (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.
A total of 24 patients suffering from RAU, they were divided into two groups each included 12 patients. The first group was treated by the propolis mucoadhesive film and the second group received the film without the active component (placebo group).Patients were handed a checklist for monitoring the actual improvement of the clinical parameters which included; duration of disappearance of pain after film application (hours), duration of complete healing of the aphthous ulcer (weeks), onset of ulcer size reduction after film application (days), duration of propolis film adherence onto the oral mucosa (hours) and finally the level of patient satisfaction scaled from 1-10.
Detailed description
The present study have been performed on a total of 24 patients suffering from RAU, they were divided into two groups each included 12 patients. The first group was treated by the propolis mucoadhesive film and the second group received the film without the active component (placebo group). Patients were recruited from the out-patient clinic of the Faculty of Dentistry, British University in Egypt during a period of 6 months.
Patients were subjected to thorough clinical examination and history obtaining in order to diagnose the oral ulcer by an oral medicine specialist, they were thoroughly informed about the study and only those with the oral ulcer within the first day to the third day of appearance were included in the present study.
The exclusion criteria in the present study were the presence of systemic or local disease such as hepatitis, cardiac conditions, hypertension, diabetes mellitus, renal problems, mental disorders, AIDS and also the use of any immunosuppressive drugs or systemic corticosteroids during last three months or using steroid treatment locally in last month, also any nutritional supplements, folic acid or antioxidants, pregnancy and nursing.
All patients were asked to avoid using antiseptics, antibiotics or analgesics, during the study as they might aid in curing the oral ulcers. Patients were blinded of receiving either propolis or placebo. They were warned about the potentiality of allergic responses that could happen to some people and that in case of occurrence of such side effect immediate termination of using the film should be implemented.
The patients were first instructed how to apply the mucoadhesive film of 2 cm2 on the oral ulcer and pasted by applying a light force with the finger tip for 20 s, and then were asked to apply it two times per day and to refrain from eating for at least one hour after the film application on the oral ulcer.
Patients were handed a checklist for monitoring the actual improvement of the clinical parameters which included; duration of disappearance of pain after film application (hours), duration of complete healing of the aphthous ulcer (weeks), onset of ulcer size reduction after film application (days), duration of propolis film adherence onto the oral mucosa (hours) and finally the level of patient satisfaction scaled from 1-10. After total healing of the oral RAU, checklists were recollected from patients, the results were tabulated and statistical analysis were conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Volunteers will be divided into two groups; each group contained 12 volunteers who will receive one formula of the selected formulae
| Arm | Type | Receives |
|---|---|---|
| Niosomal PPE oromucoadhesive film | Experimental | Drug: Niosomal PPE oromucoadhesive film, Drug: Oromucoadhesive filmNiosomal PPE oromucoadhesive film in which PPE entrapped in niosomes then incorporated in oromucoadhesive films |
| Oromucoadhesive film | Placebo comparator | Drug: Niosomal PPE oromucoadhesive film, Drug: Oromucoadhesive filmOromucoadhesive film that has no niosomal PPE in its content |
Who may qualify
- Ages
- 40 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients suffer from aphthous ulcer
Key exclusion criteria (2 listed)
- Chronic diseases ,
- Hospitalized
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 |
|---|---|---|
| Niosomal PPE oromucoadhesive filmNiosomal PPE oromucoadhesive film in which Propolis entrapped in niosomal vesicles and incorporated in oromucoadhesive film | Drug | Niosomal PPE oromucoadhesive film, Oromucoadhesive film |
| Oromucoadhesive filmOromucoadhesive film without PPE control testing which represents Placebo group | Drug | Niosomal PPE oromucoadhesive film, Oromucoadhesive film |
Primary outcome
Determination of the onset of ulcer size reduction
Time frame: Fifteen Days
Niosomal PPE in oromuco-adhesive film was prepared \& given to 12 patients to examine the onset of ulcer size reduction The patients were first instructed how to apply the mucoadhesive film of 2 cm2 on the oral ulcer and then they were handed a checklist for monitoring the actual improvement that was indicated by the reduction of the size of ulcer.
1 secondary outcome
Duration of complete ulcer healing
Time frame: Fifteen Days
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 6 Aug 2018.
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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.
Mona G Arafa, PhD principal investigator
British University In Egypt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Niosomal PPE oromucoadhesive film and Oromucoadhesive film in people with Drug Effect and Drug Effect Prolonged, run by British University In Egypt at 2 sites 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 1 inclusion and 2 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 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Determination of the onset of ulcer size reduction (time frame: Fifteen Days). 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 6 Aug 2018.