Determining the effect of safflower seed oily food product in the treatment of melasma
Design
A controlled randomized clinical trial, double blinded, phase 3 on 40 patients, using Random Allocation Software for randomization.
Settings and conduct
Samples include the patients with melasma who refer to the Shahid Faghih Dermatology Clinic. In order to blind the investigator and patients, medications are named as A for capsule of safflower seeds oil and B for placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of melasma by a dermatologist; The patient is bound to cooperate for regular use of the studied drug and refer at the appointed time; Having informed and written consent to participate in the study; Satisfaction with not using out-of-protocol therapies. Exclusion criteria: ;Pregnant and lactating women; History of hypersensitivity reaction to safflower seeds; Patient dissatisfaction to continue the project for any reason; Individuals with diabetes; Taking skin lightening medications in the last two weeks; Taking hormonal contraceptives and other medications that cause melasma; Taking anticoagulants (aspirin, Plavix, warfarin); Individuals with coagulation diseases.
Intervention groups
Intervention group: Patients in the intervention group will receive 8 grams of oily capsule containing safflower seed oil (manufactured by Barij Company) orally, daily. Also, patients in this group will use hydroquinone 4% cream (made by Pars Daroo company) every night for two hours before going to bed.
Placebo group: Patients in the placebo group will receive 8 grams of paraffin-containing capsules (made by Barij Company) orally, daily. Also, these patients will use 4% hydroquinone cream made by Pars Daroo company every night for two hours before going to bed.
Main outcome variables
The amount of melanin pigment in the site of melasma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150825023753N15
Registration date:2020-10-18, 1399/07/27
Registration timing:registered_while_recruiting
Last update:2020-10-18, 1399/07/27
Update count:0
Registration date
2020-10-18, 1399/07/27
Registrant information
Name
Mohammad Mahdi Parvizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5592
Email address
parvizim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-11, 1399/07/20
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of oily oral product of Carthamus tinctorius in comparison with placebo on the treatment of melasma: a randomized controlled clinical trial
Public title
Efficacy of oral safflower oil in treatment of melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of melasma by a dermatologist
The patient is bound to cooperate for regular use of the studied drug and refer at the appointed time
Having informed and written consent to participate in the study
Satisfaction with not using out-of-protocol therapies
Exclusion criteria:
Pregnant and lactating women
Individuals with other organ disorders (cancers, liver, kidney)
History of hypersensitivity reaction to safflower seeds
39/5000Patient dissatisfaction to continue the project for any reason
Individuals with diabetes
Taking skin lightening medications in the last two weeks
Taking hormonal contraceptives and other medications that cause melasma
Taking anticoagulants (aspirin, Plavix, warfarin)
Individuals with coagulation diseases
History of hypersensitivity to safflower seeds
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation software Ink is used to create blocks. Then, patients based on their allocated numbers are placed in groups A or B considering the designed table.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the investigator, medications were named A (oily capsule of safflower) and B (Placebo). The patients were not aware of which drug they received. The groups were also coded A and B to the statistical analyzer
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand blv., Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Approval date
2020-04-08, 1399/01/20
Ethics committee reference number
IR.SUMS.REC.1399.126
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
The rate of melasma discoloration
Timepoint
Measurements are taken at the start of the study, one month and two months after the start of the study
Method of measurement
Using Visioface 1000D and The Melasma Area and Severity Index (MASI)
Secondary outcomes
1
Description
Quality of life of patients with melasma
Timepoint
This variable is measured at the beginning of the study and two months later.
Method of measurement
The Melasma Quality of Life scale (MELASQOL)
Intervention groups
1
Description
Intervention group: Patients in the intervention group will receive 8 grams of oily capsule containing safflower seed oil (manufactured by Barij Company) orally, daily. Also, patients in this group will use hydroquinone 4% cream (made by Pars Daroo company) every night for two hours before going to bed.
Category
Treatment - Drugs
2
Description
Control group: Patients in the placebo group will receive 8 grams of paraffin-containing capsules (made by Barij Company) orally, daily. Also, these patients will use 4% hydroquinone cream made by Pars Daroo company every night for two hours before going to bed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi Dermatology Clinic
Full name of responsible person
Dr. Nasrin Saki
Street address
Shahid Faghihi Hospital, Zand Avenue
City
Shiraz
Province
Fars
Postal code
71348466114
Phone
+98 71 3212 5592
Email
nasrinsa85@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghsemi
Street address
7th floor,Vice Chancellor of Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
vcrdep@sums.ac.ir
Grant name
98-01-65-21047
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mahdi Parvizi
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand Ave, Shahid Faghihi Hospital,
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
mmparvizi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mahdi Parvizi
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand Ave, Shahid Faghihi Hospital,
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
mmparvizi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mahdi Parvizi
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand Ave, Shahid Faghihi Hospital,
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
mmparvizi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic data and the result of the clinical trial
When the data will become available and for how long
One year later
To whom data/document is available
Researchers
Under which criteria data/document could be used
After publication of the extracted article of the clinical trial
From where data/document is obtainable
Sending Email to the researchers
What processes are involved for a request to access data/document