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
|
|
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
|
|
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. |