The Efficacy oral Terbinafine alone and combined with 20% topical urea in the treatment of Pediatric Dermatophytosis and Prevention of Chronicity and Recurrence. A double-blind Randomized control trail.
To assess the efficacy of topical urea in combination with oral terrbinafine for the treatment of childhood dermatophytosis
Design
Randamized control trial
Settings and conduct
Lady reading hospital,Department of pediatrics
Participants/Inclusion and exclusion criteria
inclusion criteria:patient with superficial dermatophytosis between age 2-14 years
exclusion criteria:
Intervention groups
1.using terbinafine alone
2.using terbinafine along with topical urea
Main outcome variables
1. Clinical cure
2.prevention of chronicity and recurrence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250131064579N1
Registration date:2025-03-09, 1403/12/19
Registration timing:prospective
Last update:2025-03-09, 1403/12/19
Update count:0
Registration date
2025-03-09, 1403/12/19
Registrant information
Name
MUHAMMAD FAHIM
Name of organization / entity
Lady Readin Hospital Peshawar,KPK,Pakistan
Country
Pakistan
Phone
+92 346 5354921
Email address
muhammad.faheemyaseen@lrh.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-01, 1404/01/12
Expected recruitment end date
2025-09-01, 1404/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy oral Terbinafine alone and combined with 20% topical urea in the treatment of Pediatric Dermatophytosis and Prevention of Chronicity and Recurrence. A double-blind Randomized control trail.
Public title
keratolytics for dermatophytosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with dermatophytes infection diagnosed on clinical grounds, between age2-14 and willing to participate in the study.
Exclusion criteria:
Patients with history of any topical or systemic antifungals used for the current infection, patients with diabetes mellitus or any other immunosuppression or having history of sensitivity to terbinafine or topical urea. Similarly, patients with past or current hepatitis or other liver diseases were considered ineligible for the trial. Finally patients with T.capitis and onychomycosis were not considered due to prolonged treatment regimes
Age
From 2 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization with individual patient as unit using technique of sealed envolops
Blinding (investigator's opinion)
Double blinded
Blinding description
In this trial, participants would be randomly assigned to either group 1 (receiving the terbinafine) or group 2 (receiving topical urea with terbinafine). Both the participants and the clinical staff administering the medication or measuring outcomes would not know which group a participant is in. T
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional review board, lady reading hospital
Street address
old city,near bala hisar fort
City
peshawar
Postal code
25100
Approval date
2024-09-04, 1403/06/14
Ethics committee reference number
328/LRH/MTI
Health conditions studied
1
Description of health condition studied
Dermatophytosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Clinical improvement in skin lesions
Timepoint
Followup at weekly intervals and finally at 4thweek
Method of measurement
By assessing the parameters like complete remission(disappearance of all lesions),chronic and recurrent cases in both groups
Secondary outcomes
1
Description
chronicity and recurrence of dermatophytosis
Timepoint
4 weekly and then finally at 6 months
Method of measurement
clinical assessment of recurrent and chronic cases in both groups
Intervention groups
1
Description
Intervention group:
Category
Treatment - Drugs
2
Description
Intervention group:
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Lady reading hospital
Full name of responsible person
Dean, lady reading hospital
Street address
old city ,Peshawar, near bala hisar fort
City
peshawar
Postal code
25100
Phone
+92 91 9211430
Email
hr@lrh.gov.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lady reading hospital
Full name of responsible person
Dean
Street address
Old city,near bala hisar fort
City
Peshawar
Postal code
25100
Phone
+92 91 9211430
Email
hr@lrh.gov.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lady reading hospital
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
lady reading hospital
Full name of responsible person
aiza ur rahman
Position
trainee medical officer
Latest degree
Bachelor
Other areas of specialty/work
Pediatrics
Street address
old city near bala hisar fort
City
peshawar
Province
kpk
Postal code
25100
Phone
+92 302 8124881
Email
mr.aizazurrahman@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lady reading hospiatl
Full name of responsible person
Muhammad Fahim
Position
Trainee medical officer
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
old city near bala hisar fort
City
peshawar
Province
kpk
Postal code
25100
Phone
+92 346 5354921
Email
clinicaldermatologist@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
lady reading hospital
Full name of responsible person
abdul wasay khan
Position
trainee medical officer
Latest degree
Bachelor
Other areas of specialty/work
Pediatrics
Street address
old city,near bala hisar fort
City
peshawar
Province
kpk
Postal code
25100
Phone
+92 334 9283239
Email
awkkmc2015@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Even with de-identification, there's a risk of re-identification. Patient didnot give consent for sharing the data with third party