A comparative study of the efficacy of topical metformin cream versus placebo in the treatment of melisma
Design
In a four-phase clinical trial, 60 patients with melasma were studied in either the 15% metformin group or the placebo group. Patients were not aware of the type of drug. Also, the analyst did not know the type of drug
Settings and conduct
In a four-phase clinical trial, 60 patients with melasma referred to Dermatology Clinic of Ahvaz Imam Khomeini Hospital were studied in either the 15% metformin group or the placebo group. Medication or placebo was taken twice a day for three months. Patients were monitored on a monthly basis and MASI score was calculated and photographed before and at each visit.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with melasma referred to Dermatology Clinic of Ahvaz Imam Khomeini Hospital
Exclusion criteria: Patients who do not wish to continue treatment
Intervention groups
Intervention group: The 15% metformin cream was used twice a day for three months
Control group: Placebo was used twice a day for three months
Main outcome variables
Improvement of MASI score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121104011363N3
Registration date:2019-01-14, 1397/10/24
Registration timing:retrospective
Last update:2019-01-14, 1397/10/24
Update count:0
Registration date
2019-01-14, 1397/10/24
Registrant information
Name
Hannaneh Davoodzadeh
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8255
Email address
davoodzadeh.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2019-03-16, 1397/12/25
Actual recruitment start date
2017-08-23, 1396/06/01
Actual recruitment end date
2018-12-14, 1397/09/23
Trial completion date
2018-12-14, 1397/09/23
Scientific title
A comparative study of the efficacy of topical metformin cream versus placebo in the treatment of melisma
Public title
A comparative study of the efficacy of topical metformin cream versus placebo in the treatment of melisma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with melasma referred to Dermatology Clinic of Ahvaz Imam Khomeini Hospital
Exclusion criteria:
Pregnancy
Breastfeeding
Patients receiving hormone therapy
Atrophy and telangiectasia in the place of melasma
Use of topical treatment for melasma in the last 3 months
History of drug sensitivity
GFR less than 30
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
1234567899
Approval date
2018-09-15, 1397/06/24
Ethics committee reference number
IR.AJUMS.REC.1397.391
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
Improvement of MASI score
Timepoint
At the end of every month and 3 months after improvement
Method of measurement
MASI score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The 15% metformin cream was used twice a day for three months
Category
Treatment - Drugs
2
Description
Control group: Placebo was used twice a day for three months