Introduction: Melasma is an acquired hypermelanosis disease and its treatment is unsatisfactory most of the times.androgenic hormons may have role in pathogenesis of the melasma, and sex-hormone related drugs may have an effect on melasma. So, this study was carried out in order to comparison of efficacy of oral finastride and topical hydroquinone versus placebo and topical hydroquinone in treatment of melasma in women patients referring to Imam Hospital in Ahwaz.
Materials and Methods: This is a randomized double-blind clinical trial study conducted on 30 patients with melasma in 2015. The patients was randomly assigned in to two groups. The first group treated with finastride 5mg with 4% topical hydroquinone, and the second group treated with placebo plus 4% topical hydroquinone. Demographic and clinical characteristics as well as Melasma Area and Severity Index (MASI) and patient satisfaction will investigated. The collected data will analyzed by the SPSS software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031627077N1
Registration date:2016-05-28, 1395/03/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-28, 1395/03/08
Registrant information
Name
Ziba Mehrjuyi
Name of organization / entity
Ahwaz Jondishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 6168
Email address
mehrjuyi.z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
no funding
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of oral finastride and topical hydroquinone versus placebo and topical hydroquinone in treatment of melasma
Public title
The effect of finasteride for the treatment of melasma
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: patient with melasma and would like to participate in the study
exclusion criteria: pregnant and lactating women, patients treated with anti androgenic drugs, oral contraceptive use
Age
From 18 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz Jondishapur University of Medical Sciences
Street address
Jondishapur University of Medical Sciences, Golestan street
City
Ahwaz
Postal code
00986155615743
Approval date
2015-05-30, 1394/03/09
Ethics committee reference number
IR.AJUMS.REC.1394.101
Health conditions studied
1
Description of health condition studied
melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
melasma
Timepoint
Baseline, the end of the first month, the end of second month, the end of the third month
Method of measurement
By observing the amount of blur, uniformity and percentage of skin involvement in four areas of the forehead, right cheek, left cheek and chin
Secondary outcomes
1
Description
Satisfaction with treatment
Timepoint
end of treatment
Method of measurement
Interviews with patients
Intervention groups
1
Description
Control Group: In this group 15 patients received a placebo orally, along with topical hydroquinone 4% daily for three months.Monthly patients response to treatment and side effects are examined
Category
Treatment - Drugs
2
Description
The intervention group: The group of 15 patients with finasteride 5 mg orally on a daily basis with topical hydroquinone 4% treated on a daily basis for tree month . complications and response to treatment are evaluated monthly