Evaluating the Effectiveness of 5% Terminalia Chebula Retz. In Melasma Treatment
Design
This study is a randomized, double-blind clinical trial with a parallel group design of 48 patients
Settings and conduct
Patients are selected from Afzalipour Hospital of Kerman. Participants and physicians are blinded. The patients are assessed at baseline and after 4 and 8 and 12 weeks of using each cream based on Modified Melasma Area and Severity Index.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women in the 18-55 age range with melasma
Exclusion criteria: Pregnancy, lactation, antiepileptic drugs and spironolactone Thyroid disorders, polycystic ovary syndrome, anti-smear drug use during last 6 months, Use of oral and phototoxic contraceptives since last month, sensitivity to hydroquinone or Terminalia Chebula
Intervention groups
The treatment group use 5% cream containing the extract of Cable Harleys once in the night and the control group use 2% Hydroquinone
Main outcome variables
Modified Melasma Area and Severity Index (MMASI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110310006026N10
Registration date:2019-09-29, 1398/07/07
Registration timing:registered_while_recruiting
Last update:2019-09-29, 1398/07/07
Update count:0
Registration date
2019-09-29, 1398/07/07
Registrant information
Name
Fatemeh Dabaghzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5034
Email address
dabaghzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-22, 1398/06/31
Expected recruitment end date
2020-01-19, 1398/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Myrobalan (Terminalia Chebula.) cream, 5% compared to hydroquinone cream, 2% in the treatment of melasma
Public title
"Effect of Terminalia Chebula in treatment of melasma"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women in the 18-55 age range with melasma
Exclusion criteria:
Pregnancy, lactation, antiepileptic drugs and spironolactone Thyroid disorders, polycystic ovary syndrome, anti-smear drug use during last 6 months, Use of oral and phototoxic contraceptives since last month, sensitivity to hydroquinone or Terminalia Chebula
Age
From 18 years old to 55 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
The eligible participants are allocated to one of the two study groups in a 1:1 ratio. Allocation is by block randomization with a block size of four. A person (not involved in the trial) generates allocation sequence
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and physician:
The packaging of hydroquinone and Terminalia Chebula are similar in color and shape.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Beginning of Jahad Blvd., Tahmasebad Fourways
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2019-08-24, 1398/06/02
Ethics committee reference number
IR.KMU.REC.1398.254
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
Melanin
Timepoint
At the beginning of treatment and at the end of weeks 4, 8 and 12
Method of measurement
Modified Melasma Area and Severity Index (MMASI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 5% myrobalan cream which rub a thin layer of medicine every night and wash face in the morning.
Category
Treatment - Drugs
2
Description
Control group: 2% hydroquinone cream which rub a thin layer of medicine every night and wash face in the morning.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzali Pour hospital of Kerman
Full name of responsible person
Fatemeh Dabaghzadeh
Street address
Haft bagh high way
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5212
Email
fatemeh.dabaghzadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhtyi
Street address
Beginning of Jahad Blvd., Tahmasebad Fourways
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3815
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Dabaghzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical pharmacy
Street address
Faculty of Pharmacy, Kerman University of Medical Sciences , Haft Bagh ave, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5034
Fax
+98 34 3132 5003
Email
fatemeh.dabaghzadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Dabaghzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Pharmacy
Street address
Faculty of Pharmacy, Kerman University of Medical Sciences , Haft Bagh ave, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5034
Fax
+98 34 3132 5003
Email
fatemeh.dabaghzadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Dabaghzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Pharmacy
Street address
Faculty of Pharmacy, Kerman University of Medical Sciences , Haft Bagh ave, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5034
Fax
+98 34 3132 5003
Email
fatemeh.dabaghzadeh@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 further 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