Melasma is a common acquired hyperpigmentation seen mainly in women and occurs on the face. This study aims to compare the effects of liposomal and conventional hydroquinone on patients with Melasma. Patients with age over 18 years old are included in the study and asked to fill out written consent forms.Then patients who have exclusion criteria like pregnancy and breastfeeding, drug use, infectious skin diseases, not having regular follow ups and etc will be excluded from study.
A double blind clinical trial is conducted among 20 women for 12 weeks. Participants are asked to use liposomal hydroquinone on one side of face and topical hydroquinone on the other side of face once a day and sunblock every 3 hours a day. Skin pigmentation is then measured using MASI (Melasma area severity index) during each visit separately for each side and 1 month after last visit. Then the data obtained from patients file are statistically analyzed using SPSS software, paired samples T test and repeated measured ANOVA.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201405283862N13
Registration date:2017-10-09, 1396/07/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-09, 1396/07/17
Registrant information
Name
Farahzad Jababri Azad
Name of organization / entity
Mashahd University of Medical Scineces
Country
Iran (Islamic Republic of)
Phone
+98 51 1843 6626
Email address
banihashemim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2013-12-02, 1392/09/11
Expected recruitment end date
2017-09-22, 1396/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study between conventional and liposomal topical hydroquinone 4 % on melasma treatment
Public title
Comparison of the effect of conventional and liposomal topical hydroquinone 4 % on melasma treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Clinical Melasma; age over 18.
Exclusion criteria: Pregnancy or breastfeeding; Infectious skin diseases;
Simultaneous important medical conditions; Drug use (OCP, anticonvulsants, recent hormone therapy and Corticosteroids); Patients who used bleaching drug treatment in the last 4 months; Patients who had laser and IPL operations in the last 6 months; Patients who did not have follow ups at regular appointed times; In case of side effects.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
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 of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Postal code
Approval date
2014-02-08, 1392/11/19
Ethics committee reference number
IR.MUMS.REC.1392.806
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
disease severity
Timepoint
once a month and one month after last visit
Method of measurement
Melasma area severity index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: liposomal hydroquinone %4 was prescribed for one side of face once a day and also use of sunblock every 3 hours daily for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: conventional topical hydroquinone %4 was prescribed for one side of face once a day and also use of sunblock every 3 hours daily for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Dr Faeze Golnouri
Street address
Ahmad Abad Avenue, Ghaem Hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
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 of Mashhad University of 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Faeze Golnouri
Position
Dermatology Assistant
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmad Abad Avenue
City
Mashhad
Postal code
Phone
+98 51 3801 2493
Fax
Email
golnourif92@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mahnaz Banihashemi
Position
Professor of dermatology
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmad Abad Avenue
City
Mashhad
Postal code
Phone
00285138012493
Fax
Email
banihashemim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Akram Momenzadeh
Position
Bachelor of Biology
Other areas of specialty/work
Street address
Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences
City
Mashhad
Postal code
Phone
00
Fax
Email
src@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)