(1) Mean (Melasma area & severity Index) MASI Score in two groups of patients treated with hydroquinone and azelaic acid at intervals of zero, one, two and four months after the start of treatment, (2) This randomized, double-blind, single-center to compare the efficacy four percent hydroquinone treatment with azelaic acid 20% in patients with a clinical diagnosis of melasma melasma from February 94 to February 95 referred to dermatology clinic of Hamedan farshchian done, (3) the number of patients studied 44 people divided into two groups and drug hydroquinone and azelaic for a group to another group used, (4) Exclusion criteria: Patients who are pregnant or breastfeeding. Patients who are treated with anticonvulsant and corticosteroid drugs. Patients who are treated with OCP. Out Worker's patients. Patients who have a history of sensitivity to AZ or HQ. (5) hydroquinone and azelaic acid, each for a group of drugs used, (6) the amount of recovery based on the benchmark MASI periods of zero, one month, two months and four months after Sharveh treatment with azelaic acid groups and In both groups is hydroquinone.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2014110919885N1
Registration date:2016-01-31, 1394/11/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-31, 1394/11/11
Registrant information
Name
Hazhir Seifpanahi-Shabani
Name of organization / entity
Hamadan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0315
Email address
h.seifpanahi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Hamadan University of Medical Sciences.
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of hydroquinone 4% and 20% Zlvyyk acid in the treatment of melasma
Public title
treatment of melasma
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: melasma patients with a clinical diagnosis.
Exclusion criteria: Patients who are pregnant or breastfeeding; Patients who are treated with anticonvulsant and corticosteroid drugs; Patients who are treated with OCP; Out Worker's patients; Patients who have a history of sensitivity to AZ or HQ; Patients with underlying systemic disease (hypothyroidism and liver function Diss) are; Patients who have used a local drug during the previous month.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan university of medical science
Street address
Hamadan
City
Hamadan
Postal code
Approval date
2014-01-21, 1392/11/01
Ethics committee reference number
پ/16/35/9/3584
Health conditions studied
1
Description of health condition studied
melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
MASI score
Timepoint
0, 1, 2 and 4 months
Method of measurement
checklist
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group 2: Hydroquinone 4%, will be used once a day for 4 months.
Manufacturing by Behvazan Pharmaceutical Company.
Category
Treatment - Drugs
2
Description
Intervention group 1: Azelaic acid 20%, to be applied once a day for 4 months.
Manufacturing by Sepidaj Pharmaceutical Companies.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan Farshchian Sina Hospital
Full name of responsible person
Dr Mozhgan Bahadori
Street address
Farshchian Sinai Medical Center, Street Mirzadeh Love, Hamedan.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Hamadan university of medical science
Full name of responsible person
Mrs Yadollahzadeh
Street address
Vice chancellor for research Hamadan University of Medical Sciences, Street Shahid Fahmideh, Hamadan.
City
Hamadan
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, Hamadan university of medical science
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
Department of Dermatology University of Medical Sciences
Full name of responsible person
Dr Mozhgan Bahadori
Position
Dermatology Resident
Other areas of specialty/work
Street address
Farshchian Sinai Medical Center, Street Mirzadeh Love, Hamedan.
City
Hamadan
Postal code
Phone
+98 81 3828 0283
Fax
Email
h.seifpanahi@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Dermatology University of Medical Sciences
Full name of responsible person
Dr Mozhgan Bahadori
Position
Dermatology Resident
Other areas of specialty/work
Street address
Farshchian Sinai Medical Center, Street Mirzadeh Love, Hamedan.
City
Hamadan
Postal code
Phone
+98 81 3828 0283
Fax
Email
h.seifpanahi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Dermathology, Hamadan University of Medical Scienses
Full name of responsible person
Dr Mozhgan Bahadori
Position
Dermathology Resident
Other areas of specialty/work
Street address
Farshchian Sinai Medical Center, Street Mirzadeh Love, Hamedan.
City
Hamadan
Postal code
Phone
+98 81 3828 0283
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)