Niosomal Propolis as Oromucoadhesive Film: In-vitro, Ex-vivo & In-vivo Investigations

NCT03615820 | Completed Phase 1

• 1 other identifier: PPEADHNIO-2018-4
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Drug Effect; Drug Effect Prolonged

Keywords

Nanovesicles; Aphthous ulcer

Outcome Measures

Primary Outcomes (1)

• 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.

  Fifteen Days

Secondary Outcomes (1)

• Duration of complete ulcer healing

  Fifteen Days

Study Arms (2)

Niosomal PPE oromucoadhesive film

EXPERIMENTAL

Niosomal PPE oromucoadhesive film in which PPE entrapped in niosomes then incorporated in oromucoadhesive films

Drug: Niosomal PPE oromucoadhesive film; Drug: Oromucoadhesive film

Oromucoadhesive film

PLACEBO COMPARATOR

Oromucoadhesive film that has no niosomal PPE in its content

Drug: Niosomal PPE oromucoadhesive film; Drug: Oromucoadhesive film

Interventions

Niosomal PPE oromucoadhesive film DRUG

Niosomal PPE oromucoadhesive film in which Propolis entrapped in niosomal vesicles and incorporated in oromucoadhesive film

Niosomal PPE oromucoadhesive film; Oromucoadhesive film

Oromucoadhesive film DRUG

Oromucoadhesive film without PPE control testing which represents Placebo group

Niosomal PPE oromucoadhesive film; Oromucoadhesive film

Eligibility Criteria

• Age: 40 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients suffer from aphthous ulcer

You may not qualify if:

• Chronic diseases ,
• Hospitalized

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (2)

Mona G Arafa

New Cairo, Cairo Governorate, 11837, Egypt

Location

Mona G Arafa

Cairo, 11837, Egypt

Location

MeSH Terms

Conditions

Stomatitis, Aphthous

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mona G Arafa, PhD

  The British University in Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Volunteers will be divided into two groups; each group contained 12 volunteers who will receive one formula of the selected formulae

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: August 6, 2018
• Study Start: January 1, 2018
• Primary Completion: January 30, 2018
• Study Completion: January 30, 2018
• Last Updated: August 6, 2018

Record last verified: 2018-07

Locations

EG (2)