Objectives: This interventional study as a randomized double blind would be clinical trial of Evaluation of Methimazole 5% cream effectiveness versus Hydroquinone 2% cream to reduce melasma.
Design: 50 patients with melasma in two groups of patients as controls and cases, each group consisted of 25 patients. Both treatment and advantages and disadvantages of each will be explained.
Setting and conduct: At first patients will be asked to vote thyroid function tests. Cases will be treated with Methimazole 5% cream nightly for 8 weeks. The control group will be treated with Hydroquinone 2% cream nightly for 8 weeks.
Inclusion criteria: Ages from 18 to 50; Normal to dry skin; without comedones
Exclusion criteria: Absence of fallow up by patients and not satisfied to continue; Complications such as allergy to topical agent; Pregnancy and lactation; Thyroid disease; Oral contraceptive pills use and other drugs that cause melasma
Intervention: The response to treatment based on visioface images.
Outcome measures variables: Data collection is done by forms of patient information concerning the patient information, age and co morbidity. Then patients will be reassessing to evaluate response to treatment visioface photography and MASI system. In order to ensure that the drug's effect on thyroid hormones, again, thyroid function tests for patients will be asked at the end of the period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016073129145N1
Registration date:2016-12-05, 1395/09/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-05, 1395/09/15
Registrant information
Name
Sedighe Naeji
Name of organization / entity
Iran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4401 1989
Email address
naeji.s@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences.
Expected recruitment start date
2016-08-05, 1395/05/15
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Methimazole 5% cream effectiveness versus Hydroquinone cream 2% in patient with melasma, referred to Dermatology Clinic
Public title
Clinical trial of evaluation of Methimazole 5% cream effectiveness versus Hydroquinone cream 2% to reduce pregnancy spots (melasma)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Ages from 18 to 50; Normal to dry skin; without comedones
Exclusion criteria: Absence of follow up by patients and not satisfied to continue; Complications such as allergy to topical agent; Pregnancy and lactation; Thyroid disease; Oral contraceptive pills use and other drugs that cause melasma.
Age
From 18 days old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
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 of Iran University of Medical Sciences
Street address
Iran University Of Medical Sciences, Adjacent to the Milad Tower, Hemat Highway, Tehran
City
Tehran
Postal code
Approval date
2015-11-30, 1394/09/09
Ethics committee reference number
IR.IUMS.REC.1394.27226
Health conditions studied
1
Description of health condition studied
melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
Hyperpigmentation of face skin
Timepoint
At first and 8 weeks after treatment
Method of measurement
Intensity of the darkening of the face skin compared to other areas of the face with visioface device.
Secondary outcomes
1
Description
Satisfaction amount
Timepoint
After completion of treatment
Method of measurement
Comparison of reduction hyperpigmentation by patient, before and after treatment According to schedule
Intervention groups
1
Description
Intervention group 1: Cases will be treated with Methimazole 5% topical cream once a night for 8 weeks.
Category
Treatment - Drugs
2
Description
Intervenion group 2: The control group will be treated with Hydroquinone topical cream 2% once a night for 8 weeks.