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CTRI Number  CTRI/2018/08/015305 [Registered on: 13/08/2018] Trial Registered Prospectively
Last Modified On: 10/08/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing the effectiveness of terbinafine cream and ciclopirox cream alone and in combination in the treatment of ringworm (fungal infection) 
Scientific Title of Study   Comparative efficacy of 1% terbinafine hydrochloride cream and 1% ciclopirox olamine cream alone and in combination in the treatment of dermatophytosis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Karan Chhabra 
Designation  Post Graduate Resident 
Affiliation  Goverment Medical College and Hospital, Chandigarh 
Address  Department of Dermatology, Goverment Medical College and Hospital, Sector 32, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  8146748987  
Fax    
Email  justkaran27@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mala Bhalla 
Designation  Professor 
Affiliation  Goverment Medical College and Hospital, Chandigarh 
Address  Department of Dermatology, Goverment Medical College and Hospital, Sector 32, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121545  
Fax    
Email  malabhalla@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Karan Chhabra 
Designation  Post Graduate Resident 
Affiliation  Goverment Medical College and Hospital, Chandigarh 
Address  Department of Dermatology, Goverment Medical College and Hospital, Sector 32, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  8146748987  
Fax    
Email  justkaran27@gmail.com  
 
Source of Monetary or Material Support  
Department of Dermatology, Goverment Medical College and Hospital, Sector 32, Chandigarh 
 
Primary Sponsor  
Name  Department of Dermatology 
Address  Department of Dermatology, Goverment Medical College and Hospital, Sector 32, Chandigarh 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Karan Chhabra  Goverment Medical College and Hospital, Sector 32, Chandigarh  Skin Opd,B-block, 4th floor,Goverment Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH 
8146748987

justkaran27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B359||Dermatophytosis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GROUP 1   20 patients with topical 1% terbinafine hydrochloride cream twice daily for 6 weeks. 
Comparator Agent  GROUP 2  20 patients with topical 1% ciclopirox olamine cream twice daily for 6 weeks 
Comparator Agent  GROUP 3  20 patients with terbinafine hydrochloride cream once daily in the morning and 1% ciclopirox olamine cream once daily in the evening for 6 weeks 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Koh positivity on direct microscopy showing septate hyphae of dermatophytosis
2. Body surface area less than 10%, not requiring systemic therapy
3. All age groups involved
 
 
ExclusionCriteria 
Details  1. Patients with co-existing dermatophytosis involving hair, nail, palms and soles
2. Patients who have used any antifungal drugs or steroids in the last 4 weeks
3. Pregnant and lactating women
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
All the patients will be assessed for therapeutic results by clinical evaluation and KOH examination at 3, 6 and 9 weeks of initiation of therapy. Complete resolution of lesions except residual pigmentary changes shall be regarded as clinical cure and KOH negativity shall be regarded as mycological cure.Those achieving complete cure will be followed up at 9th week to look for any relapse.  3 weeks
6 weeks
9 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/08/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Dermatophytosis is the most common form of mycoses which affects more than 25% of the world’s population. Dermatophytes include fungi belonging to the genera Trichophyton Microsporum and Epidermophyton which preferentially infect epidermal keratinized tissues. Infections are usually confined to the stratum corneum and dermal appendages, especially in the moist areas of the body, such as the regions between the toes, groin and inframammary area. Dermatophytes do not cause mortality, but they cause morbidity and are a major public health problem.

The distribution of species and the clinical characteristics vary with variable geographic localization, environmental and cultural factors. Trichophyton rubrum is the most common causative agent of dermatophytosis followed by Trichophyton mentagrophytes. Many factors including age, gender, living conditions, social class and underlying diseases like diabetes mellitus affect the frequency of infection with dermatophytes. Hot and humid climate in tropical and subtropical countries like India makes dermatophytosis a very common superficial fungal skin infection. Diagnosis of these mycoses is usually made clinically and confirmed by direct microscopy, fungal culture and identification of the species.

Various antifungal agents, both in oral and topical forms have been developed for treatment of dermatphytosis. The treatment of choice for localized tinea is topical antifungal agents, while systemic agents are used in extensive disease, follicular invasion and nail involvement.

Terbinafine is an allylamine which acts by inhibiting the squalene epoxidase enzyme in fungal cell membranes, leading to deficiency in ergosterol and accumulation of intracellular squalene. It is fungicidal and has been demonstrated to be efficacious in dermatophytosis both in its topical and oral formulation.

Ciclopirox olamine is a hydroxypyridone derivative. It is a topical fungicidal drug which has high affinity for trivalent cations such as Fe3+ and Al3+. These ions are involved in mitochondrial electron transport processes to produce energy and thus, by blocking these transports, it provokes a lack of energy production and subsequently the cell death.

 

In the recent years, injudicious use of combination creams/ over the counter preparations of antifungal agents with steroids for the treatment of dermatophytosis has led to an increase in treatment failure as well as relapses after conventional therapy. Topical terbinafine is considered the treatment of choice for localized tinea infections but clinical treatment failures are increasingly being reported. Topical ciclopirox olamine, which was primarily being used as nail lacquer for onychomycosis, has now become available in cream formulations for application on skin for dermatophytic infections.The present study aims at comparitive efficacy of topical 1% terbinafine hydrochloride and topical 1% ciclopirox olamine cream alone and in combination for the treatment of dermatophytosis.

 

 
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