Study is a single blind clinical trial. Melasmatic women constitute the study population who shouldn't be pregnant or breastfeeding and not to receive OCPs, spironolactone and phenytoin. Sample size is 40 for each group. Trial group will receive topical flutamide and control group will receive topical hydroquinone. Both groups will use anti-solar treatments. Treatment will last for 4 months and at the end of each month, improvement will be evaluated. Evaluation will be based on mexameter , photography, observations of the physician and patient satisfaction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905114310N4
Registration date:2010-08-24, 1389/06/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-08-24, 1389/06/02
Registrant information
Name
Hassan Adalatkhah
Name of organization / entity
Ardebil University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 308 6490
Email address
h.edalatkhah@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardebil medical university
Expected recruitment start date
2008-09-22, 1387/07/01
Expected recruitment end date
2013-12-01, 1392/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of topical flutamid on melasma compared with topical hydroquinon
Public title
Effects of topical flutamid on melasma lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Females with melasma
2- Consent to participate
Exclusion criteria:
1- Pregnancy
2- Breastfeeding
3- Taking OCP, spironolactone or phenytoein
4- Receiving antipigmentation therapy during the last four months
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardebil medical university
Street address
Deputy of research, Ardebil medical university, Ardebil