A randomized double- blind controlled trial was conducted to compare the effect of topical methimazole with hydroquinone . The study participants comprised 50 women 20-50 years old with epidermal type of melasma who had taken no medication within 3 months before the study and referred to the outpatient dermatology clinices of Shohada-e Tajrish Hospital and Loghman hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran during 2015. Patients were randomly divided to two groups: HQ group and MMI group. All patients recived treatments for 8 weeks and patients were advice to use only sunscreen for 4 week after the end of the treatment as well. Melasma status was assessed at the end of 4 weeks, 8 weeks and 12 w. Both the patients and outcome assessors were blinded to the type of treatment received. The creams were labeled A & B by pharmacist and used in a double blind study by the research team. The codes were disclosed by the pharmacist at the end of the trial.
Outcome of the study as pigmentation reduction was assessed through subjective and objective methods which analyzed and reported: 1. Melasma Area and Severity Index (MASI) 2. Patient satisfaction scaled 3. Physician Evaluation by two dermatologists which were blinded to therapies (they assessed digital photographs taken at baseline visit, intermediate visit at week 4 and 8, and subsequent visit at week 12 and then ranked efficacies. Safety assessment was based on the adverse effects as mentioned by the patient and evaluated by the investigator.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041727445N1
Registration date:2016-04-30, 1395/02/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-30, 1395/02/11
Registrant information
Name
Elham Olamaei
Name of organization / entity
Skin Researh center
Country
Iran (Islamic Republic of)
Phone
+98 22741507
Email address
dr.olamaei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2015-03-11, 1393/12/20
Expected recruitment end date
2015-11-20, 1394/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of hydroquinone cream 4% and methimasole cream 5% in melasma patients
Public title
Compare the effect of methimazole and hydroquinone cream in the treatment of melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:All the people in the age range of 50-20 years and all topical treatments for at least one month prior to study entry and are cut by a dermatologist examination with Wood's light examination (Wood) disease of epidermal melasma approved exclusion criteria and do not have;All people have informed consent to participate in the scheme.
Exclusion criteria:Pregnancy and lactation;There Type of melasma
3Use of any treatment for melasma in the last month;Use of oral contraceptives and hormone therapy and medication have any phototoxic;Past medical history of any thyroid disorders in patients
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Shahid Beheshti University of Medical Sciences
Street address
Arab street next Shahid Ayatollah Taleghani Hospital, Highway Chamran Street Yemen, Tehran
City
Tehran
Postal code
1985717443
Approval date
2015-03-11, 1393/12/20
Ethics committee reference number
Fourteenth meeting of the Committee descendants 93/43
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
L8101
ICD-10 code description
Chloasma
Primary outcomes
1
Description
Efficasy of methimazole 5%cream in severity of melasma with change in colore
Timepoint
Every 4 Weeks
Method of measurement
MASI Score
2
Description
Efficacy of hydroquinone 4%cream in severity of melasma with change in colore
Timepoint
Every 4 weeks
Method of measurement
MASI score
Secondary outcomes
1
Description
Side effects
Timepoint
Every four weeks
Method of measurement
Ask the patient
Intervention groups
1
Description
Control:Use 4% hydroquinone cream every night for 8 weeks
Category
Treatment - Drugs
2
Description
Case:The use of methimazole 5% cream every night for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada-Tajrish Hospital
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Luqman Hakim Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University Skin Research Centerof Medical Sciences
Full name of responsible person
parviz Toosi
Street address
Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti University Skin Research Centerof Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Skin Research Centers
Full name of responsible person
Elham Olamaei
Position
Dermatology Resident
Other areas of specialty/work
Street address
Shohada Tajrish Hospital
City
Tehran
Postal code
Phone
+98 21 2274 1507
Fax
Email
elhamolamaei@gmail .com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences Skin Research Centers
Full name of responsible person
Mehdi Gheisari
Position
MD
Other areas of specialty/work
Street address
Shohada Tajrish Hopital
City
Tehran
Postal code
Phone
+98 21 2274 1507
Fax
Email
mgheisari@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Skin Research Centers
Full name of responsible person
Elham Olamaei
Position
Dermatology Resident
Other areas of specialty/work
Street address
Shohada Tajrish Hospital
City
Tehran
Postal code
Phone
00
Fax
Email
elhamolamaei@gmail .com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)