Preparation of optimum semi-solid product from Dorema ammoniacum D. Don oleo-gum-resin;
Determination of the physical and chemical parameters of the product and its quality control;
Determine the efficacy of the product in patients with chloasma
Design
A , randomized, blinded, placebo controlled clinical trial with a parallel group design of 60 patients
Settings and conduct
recruitment of patients is carried out at Hajdahi clinic.The randomization of patients will be done using random numbers generated by computer and Excel. In this way, when every new patient enter the study, the researcher will be contacted by a third person. On the basis of a random number, the researcher will be informed that A or B is given to the patient. Patients and the person who provides the drug to patients will be unaware of the drug content.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men and women aged 14_66 years old; The patients have mild to moderate melasma according to melasma severity index (MSI).
Non inclusion criteria: The patients have used the bleaching materials during 2 weeks before intervention;
Positive pregnancy test for female participants.
Intervention groups
Intervention group: topicalpreparation from Dorema ammoniacum D. Don oleo-gum-resin
Control group: Eucerine Cream
Main outcome variables
severity of melasma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141124020071N4
Registration date:2019-01-26, 1397/11/06
Registration timing:registered_while_recruiting
Last update:2019-01-26, 1397/11/06
Update count:0
Registration date
2019-01-26, 1397/11/06
Registrant information
Name
Mohammad Hosein Farzaei
Name of organization / entity
Faculty of Pharmacy, Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3825 0271
Email address
mh-farzaee@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-06, 1397/07/14
Expected recruitment end date
2019-10-06, 1398/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Formulationand evaluation of the efficacy of topicalpreparation from Dorema ammoniacum D. Don oleo-gum-resin in patients with chloasma
Public title
The efficacy of Dorema ammoniacum D. Don oleo-gum-resin on chloasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 14_66 years old
Men and women
The patients have mild to moderate melasma according to melasma severity index (MSI)
Exclusion criteria:
The patients have used the bleaching materials within 2 weeks before intervention
Pregnancy test for female participants is positive
Age
From 14 years old to 66 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Topical formulation of Dorema ammoniacum D.Don will give to the patients that chose based on the Block randomized method and divided into two groups including case and control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the person who provides the drug to patients will be unaware of the drug content.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-12-19, 1397/09/28
Ethics committee reference number
IR.KUMS.REC.1397.743
Health conditions studied
1
Description of health condition studied
chloasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
Chloasma
Timepoint
Before using the drug _ 30 days after the drug
Method of measurement
Based on Dermatology QOL (quality of life) Question and MSI (melasma severity index)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: use of 1 grams topicalpreparation from Dorema ammoniacum D. Don oleo-gum-resin twice daily for 1 month.
Category
Treatment - Drugs
2
Description
Control group: use of 1 grams Eucerine Cream twice daily for 1 month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Haj Daie Medical clinic
Full name of responsible person
Fariba Najafi
Street address
Haj Daie Medical clinic, Golestan Ave., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3825 0271
Email
mh.farzaei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Behrooz Hamzeh
Street address
Vice Chancellor for Research, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.,
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
mh.farzaei@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Hosein Farzaei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Parastar Blvd., Daneshgah street, Kermanshah.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3825 0271
Fax
+98 83 3825 0271
Email
mh-farzaee@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Hosein Farzaei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Parastar Blvd., Daneshgah street., Kermanshah.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3825 0271
Fax
+98 83 3825 0271
Email
mh-farzaee@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Hosein Farzaei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Parastar Blvd., Daneshgah street., Kermanshah.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3825 0271
Fax
+98 83 3825 0271
Email
mh-farzaee@razi.tums.ac.ir
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 information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available