Compare the effect of Kligman plus Methimazole 5% combination against Kligman alone in the treatment of melasma
Design
This study is a randomized, blinded clinical trial with a parallel group on 44 patients.
Settings and conduct
Each patient is given two creams with the same package shape, coded A and B,The evaluating physician and the patient are both unaware of the contents of the two creams.According to the table of random numbers each patient is randomly instructed to apply A cream to the left and B cream to the right of the face or vice versa.The severity of melasma lesions is measured according to the The Melasma area and severity index (MASI) at the beginning of the study and 8 weeks after the start of the drug intervention.Patient satisfaction is measured on a VAS scale after 8 weeks of treatment.
This study was performed on patients with melasma referred to Alzahra Hospital in Isfahan.
Participants/Inclusion and exclusion criteria
Entry conditions:
All patients with melasma
No entry conditions:
pregnancy,lactation,Treatment with OCP and HRT,Use of drugs that darken the color of the skin,History of allergy to topical and systemic steroids and thyroid drugs in at least the last 30 days,History of Severe systemic disease,History of any thyroid disease
Intervention groups
Each patient is given two creams,One of the creams contains Kligman(B) and another one contains Kligman and Methimazol(A).Each of the creams is rubbed on one side of the face(split face).
Main outcome variables
MASI score,Patient satisfaction,side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200817048437N1
Registration date:2020-09-08, 1399/06/18
Registration timing:prospective
Last update:2020-09-08, 1399/06/18
Update count:0
Registration date
2020-09-08, 1399/06/18
Registrant information
Name
Mahsa Akhtari Boroujeni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3653 2286
Email address
mahsaakhtari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of Kligman plus Methimazole 5% combination against Kligman alone in the treatment of melasma
Public title
Effect of Kligman plus Methimazol in treatment of melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with melasma
Exclusion criteria:
pregnancy
lactation
Treatment with OCP and HRT
Use of drugs that darken the color of the skin
History of allergy to topical and systemic steroids and thyroid drugs in at least the last 30 days
History of Severe systemic disease
History of any thyroid disease
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
44
More than 1 sample in each individual
Number of samples in each individual:
2
Right and left side of the face
Randomization (investigator's opinion)
Randomized
Randomization description
According to the table of random numbers each patient is randomly instructed to apply A cream to the left and B cream to the right of the face or vice versa.
Blinding (investigator's opinion)
Double blinded
Blinding description
Each patient is given two creams with the same package shape, coded A and B.The evaluating physician and the patient are both unaware of the contents of the two creams.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences,Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-06-06, 1399/03/17
Ethics committee reference number
IR.MUI.MED.REC.1399.206
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 severity of melasma lesions is measured according to the The Melasma area and severity index (MASI) , which includes three factors: percentage of facial involvement, darkness and homogeneity.
Timepoint
Measurement of the Melasma area and severity index (MASI score) at the beginning of the study and 8 weeks after the start of the drug intervention
Method of measurement
The Melasma area and severity index (MASI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Each patient is given two creams,One of the creams contains Kligman(B) and another one contains Kligman and Methimazol(A).Each of the creams is rubbed on one side of the face(split face).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Majid Rezvani
Street address
Alzahra hospital,Sofeh Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy javanmard
Street address
Isfahan university of medical sciences,Hezarjerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mahsa Akhtari Boruojeni
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No D-14,Toranj Apartment,Sabur Alley,Tolu Alley,West Tohid Blvd,Sepahanshahr
City
Isfahan
Province
Isfehan
Postal code
8179981786
Phone
+98 31 3653 2286
Email
mahsaakhtari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahsa Akhtari Boruojeni
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No D-14,Toranj Apartment,Sabur Alley,Tolu Alley,West Tohid Blvd,Sepahanshahr
City
Isfahan
Province
Isfehan
Postal code
8179981786
Phone
+98 31 3653 2286
Email
mahsaakhtari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahsa Akhtari Boruojeni
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No D-14,Toranj Apartment,Sabur Alley,Tolu Alley,West Tohid Blvd,Sepahanshahr
City
Isfahan
Province
Isfehan
Postal code
8179981786
Phone
+98 31 3653 2286
Email
mahsaakhtari@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
Data are published that have nothing to do with the personality and identity of the participants in this study and are only the results of the study.
When the data will become available and for how long
The data are available six months after the publication of the article in the journal.
To whom data/document is available
Approved university researchers are allowed to access the data after being authenticated by the relevant university.
Under which criteria data/document could be used
The data can only be used for research purposes, such as writing review articles.
From where data/document is obtainable
To receive the data, the corresponding author can be accessed via the email and telephone number of the university mentioned in the article.
What processes are involved for a request to access data/document
After reviewing the data access request, if approved, it is for non-industrial and non-commercial uses, the data will be provided to the applicant.