Physico-chemical Characterization and clinical evaluation of Shallomin Liposomal Gel final formulation on cold sore
Design
Clinical trial with a control group, parallel groups design of 45 patients, double-blind randomized, zero phase, randomized using a table of random numbers
Settings and conduct
In this study researcher, participants and physician were blind. The subjects in both treatment groups were asked to use the administered medicine on the cold sore every hour until the tingling sensation and sores healed. placebo (only liposomal gel) was prepared in similar looking containers and was administered for the control group and asked them to apply it hourly on sores. Dermatologist examined the sores in both treatment groups during 12, 24, 48 and 72 hours after initiation of intervention until cold sores healed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the incidence of cold sore during the last 24 hours without treatment
Exclusion criteria: self-medication after cold sore incidence
Intervention groups
The first group: Administration of placebo
The second group: Treatment with acyclovir ointment
The third group: Treatment with shallomin liposomal gel
Participants were male and female students of Ahvaz jundishapur university of medical sciences who were examined by dermatologist and cold sore had been diagnosed for them. All volunteers were shown cold sores within 24 hours before checkup. Participants were randomly divided to three groups each included 15 students. Two groups were randomly chosen as treatment groups (first group were exposed to treatment with acyclovir and second group treated with shallomin liposomal gel) and third group was selected as control group (with administration of placebo).
Main outcome variables
Shallomin concentration, percentage of release, the mean of liposome size, lipid ratio, the amount of shallomin encapsulated liposome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200819048457N1
Registration date:2020-10-06, 1399/07/15
Registration timing:retrospective
Last update:2020-10-06, 1399/07/15
Update count:0
Registration date
2020-10-06, 1399/07/15
Registrant information
Name
Zahra Farshadzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 0250
Email address
zahra.farshadzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
2015-09-23, 1394/07/01
Actual recruitment end date
2018-05-15, 1397/02/25
Trial completion date
2018-05-15, 1397/02/25
Scientific title
Physicochemical characterization and clinical evaluation of final formulation of Shallomin liposomal gel on cold sore
Public title
Evaluation of Moosir liposomal extract on cold sore
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: the incidence of cold sore during the last 24 hours without treatment
Exclusion criteria:
Exclusion criteria: self-medication after cold sore incidence
Age
From 20 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
45
Actual sample size reached:
45
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In present study, clinical caregivers, researchers, outcome evaluators and participants are blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz jundishapur University of Medical Sciences
Street address
Ahvaz jundishapur university of medical sciences, Esfand Ave, Farvardin BLv, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Approval date
2015-09-19, 1394/06/28
Ethics committee reference number
IR.ajums.rec.1394.410
Health conditions studied
1
Description of health condition studied
Cold sore
ICD-10 code
B00
ICD-10 code description
Herpesviral [herpes simplex] infections
Primary outcomes
1
Description
wound healing
Timepoint
6, 12, 24 and 72 hours after treatment with shallomin liposomal gel
Method of measurement
Ocular
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Treatment using acyclovir ointment (5%), every 6h for 72h. Intervention group 2: Treatment using shallomin liposomal gel (1%), every 6 h for 72h.
Category
Treatment - Drugs
2
Description
Control group: Treatment using placebo every 6 h for 72h.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Reza Yaghoobi
Street address
Golestan hospital, Farvardin Blvd, Golestan region
City
Ahvaz
Province
Khouzestan
Postal code
6136835685
Phone
+98 61 3374 3001
Fax
+98 61 3374 3030
Email
Golestanjpsital@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahdi Ahmadi-moghadam
Street address
Ahvaz jundishapur university of medical sciences, Esfand St, Farvardin Blvd, Golestan region
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
iitc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mansour Amin
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Microbiology department, Faculty of medicine, ahvaz jundishapur university of medical sciences, Esfand Ave., Farvardin Blvd., Golestan Area
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 5368
Email
mnsamin@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mansour Amin
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
department of microbiology, faculty of medicine, ahvaz jundishapur university of medical sciences, esfand Ave., Farvardin Blvd., Golestan Area
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 5368
Email
mnsamin@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Farshadzadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Microbiology department, faculty of medicine, Ahvaz jundishapur university of medical sciences, esfand Ave, ّFarvardin Blvd, Golestan Highway, Ahvaz town.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 0250
Fax
Email
zahra.farshadzadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results will be presented in the form of a research paper
When the data will become available and for how long
from January 2021
To whom data/document is available
Researchers
Physicians
Pharmacists
Under which criteria data/document could be used
In order to produce the drug and in coordination with the responsible researcher, the documents can be used
From where data/document is obtainable
Dr Mansour Amin- Jundishapur university of medical aciences
What processes are involved for a request to access data/document
There is no specific process for obtaining documents, all documents can be obtained by referring to the researcher in charge