Objectives: This interventional study is a clinical trial to evaluate the fractional laser and topical antifungal effectiveness versus systemic antifungal to improve Onychomycosis. Design: 54 patients in two groups of patients as controls and interventions, each group consisted of 27 patients. Both treatment and advantages and disadvantages of each will be explained. Setting and conduct: Interventions will be treated with fractional laser and topical Terbinafine, 3 sessions with a month intervals between them. The control group will be treated with oral Terbinafine 3 sessions with a month intervals between them. A period of 6 months for follow-up, 3 and 6 months after completion of the treatment will be considered. Inclusion criteria: Onychomycosis Infection; Lack of sensitivity to topical or oral agent Exclusion criteria: Absence of follow up by patients and Lack of consent for treatment; Complications such as allergy to topical or oral agent Intervention: Fractional laser with topical antifungal in the intervention group and the oral antifungal in the control group. Outcome measures variables: Fungal nail infection is the involvement of the nail plate with standard photography.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016022925539N6
Registration date:2016-04-21, 1395/02/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-21, 1395/02/02
Registrant information
Name
Abbas Zamanian
Name of organization / entity
Iran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4401 1989
Email address
a.zamanian@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research , Iran University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of fractional laser and topical antifungal effectiveness versus systemic antifungal in patients with onychomycosis
Public title
Evaluation of fractional laser and topical antifungal effectiveness versus systemic antifungal to improve onychomycosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Onychomycosis Infection ; lack of topical or oral drug allergy
Exclusion criteria: Absence of follow up by patients and Lack of consent for treatment; Complications such as allergy to topical or oral agent
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomizing Based on the table of random numbers
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
2015-09-23, 1394/07/01
Ethics committee reference number
IR.IUMS.REC.1394 . 26856
Health conditions studied
1
Description of health condition studied
onychomycosis
ICD-10 code
B35.1
ICD-10 code description
Tinea unguium
Primary outcomes
1
Description
Fungal nail infection
Timepoint
0, 1 and 2 months during treatment . And 3 and 6 months after treatment
Method of measurement
The involvement of the nail plate with standard photography
Secondary outcomes
1
Description
Response to treatment According to the patient
Timepoint
After completion of treatment
Method of measurement
The percentage and score of the patient to treatment (0 to 100%)
2
Description
Satisfaction amount
Timepoint
After completion of treatment
Method of measurement
Comparison of reduction nail involvement by patient , before and after treatment According to schedule (score 0 to 10)
Intervention groups
1
Description
Intervention group 1 : Cases will be treated with fractional laser, 3 sessions with a month intervals between them and Terbinafine 1 % cream topically twice daily. Due to painful procedure, there is need for anesthesia.
Category
Treatment - Devices
2
Description
Control group : The control group will be treated with oral Terbinafine 250 mg tablet daily for 3 months.