(1) Objectives: Our aim in this study is to compare topical colloidal silver with topical clotrimasole in treating patients with dermatophytosis. (2) Design: This is a double blinded randomized clinical trail. Forty patients with staphylococcal-streptococcal skin infections and 40 ones with dermatophytosis referring to dermathology clinics, Sina Hospital, Tabriz will be included in the study after qualifying the inclusion and exclusion criteria and obtaining
the informed consent. Patients will be randomly assigned to one of treatment groups. For randomizing the patients we will use Excel software (computerized randomization). (3) Setting and conduct: After randomizing the patients, one group will receive topical colloidal silver and the other will be administered with clotrimasole. Neither the patient nor the supervisor doctor are aware of the administered drug. Inclusion criteria are having superficial staphylococcal-streptococcal skin infections, being more than 4 years old, not having immune disorder and organ failure, not having history of allergy to silver compounds and clotrimasole and not using topical drugs in last two weeks in the site of lesion. Exclusion criteria are unwillingness to continue participation in the study, occurring a dermatological reaction due to drugs administered and any kind of drug reaction. (4) Interventions: Patients in the first group will receive topical colloidal silver three times a day for two weeks. In the other group patients will receive topical clotrimasole two times a day for four weeks. (5) Main outcome measures: Erythema, encrustation, inflammation and exudation will be evaluated before administering drugs and at the end of treatment period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201401045092N2
Registration date:2014-08-29, 1393/06/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-29, 1393/06/07
Registrant information
Name
Effat Khodayiani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1541 2101
Email address
khodaeianie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effects of topical colloidal silver and topical clotrimasole in dermatophytosis
Public title
Comparison of two kinds of topical drugs in treatment of dermatological infections
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: superficial staphylococcal-streptococcal skin infections; age more than 4 years old; not having immune disorder and organ failure; not having history of allergy to silver compounds and clotrimasole; not using topical drugs in last two weeks in the site of lesion.
Exclusion criteria: unwillingness to continue participation in the study, occurring a dermatological reaction due to drugs administered; any kind of drug reaction.
Age
From 4 years old to 149 years old
Gender
Both
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)
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 Tabriz University of Medical Sciences
Street address
Ethics committee, Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz