| CTRI Number |
CTRI/2017/11/010418 [Registered on: 07/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
23/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effect,safety and cost of sertaconazole cream versus luliconazole cream in patients with dermatophytoses |
|
Scientific Title of Study
|
Comparative assessment of the efficacy, safety and cost effectiveness of sertaconazole (2%) cream versus luliconazole (1%) cream in patients with dermatophytoses : A prospective, Randomized , open label, parallel study |
| Trial Acronym |
CAESCESVLPDPROLPS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr ASHISH GUPTA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Government medical college, Nagpur |
| Address |
DEPARTMENT OF PHARMACOLOGY, GOVERNMENT MEDICAL
COLLEGE, NAGPUR
Nagpur
MAHARASHTRA
440003
India |
| Phone |
7057189408 |
| Fax |
|
| Email |
dr.ashish1489@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GANESH DAKHALE |
| Designation |
Professor |
| Affiliation |
Government medical college, Nagpur |
| Address |
DEPARTMENT OF PHARMACOLOGY, GOVERNMENT MEDICAL
COLLEGE, NAGPUR.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9850539353 |
| Fax |
|
| Email |
gndakhle@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr JAYESH MUKHI |
| Designation |
Associate Professor |
| Affiliation |
Government medical college, Nagpur |
| Address |
DERMATO-VENEREO-LEPROLOGY DEPARTMENT,GOVERNMENT MEDICAL
COLLEGE, NAGPUR.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9665037576 |
| Fax |
|
| Email |
jayesh.mukhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ashish gupta, Dept.of pharmacology,Govt.medical college,nagpur |
|
|
Primary Sponsor
|
| Name |
Government Medical College |
| Address |
Department of Pharmacology, Government Medical College,
Nagpur |
| 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 ASHISH GUPTA |
DERMATO-VENEREO-LEPROLOGY DEPARTMENT,GOVERNMENT MEDICAL COLLEGE ,NAGPUR |
Government
medical college,near to medical square,
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
7057189408
dr.ashish1489@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College, Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
DERMATOPHYTOSES PATIENTS, (1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LULICONAZOLE 1% CREAM |
Luliconazole is an imidazole antifungal agent,it inhibits 14a-demethylase causing fungal ergosterol biosynthesis to be disrupted.1% luliconazole cream applied once daily for 2 weeks |
| Intervention |
SERTACONAZOLE 2% CREAM |
Sertaconazole, an imidazole antifungal agent, inhibits the synthesis of ergosterol, an essential cell wall component of fungi.Sertaconazole has both fungistatic and fungicidal activity.2% sertaconazole cream applied once or twice daily for 2-4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Adults between the age group of 18 to 70 years of either gender, with clinical diagnosis and mycological confirmation (positive KOH test) for tinea corporis and tinea cruris infections, will be included in the study.
2)Patient having a Physician global assessment (PGA) composite score of at least 5 will be included in the study.
3)Patient willing to give written informed consent will be included in the study
|
|
| ExclusionCriteria |
| Details |
1)Patients having clinical diagnosis of tinea infections other than tinea corporis and tinea cruris,
2)Patients having extensive fungal infection,
3)Patients who had received topical or oral antifungal agents upto four weeks prior to the initiation of the study,
4)History of hypersensitivity to study drugs,
5)Immunocompromised patients,
6)Patients having superadded bacterial infection,
7)Pregnant or lactating women |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare the efficacy of sertaconazole (2%) cream versus luliconazole (1%) cream in patients with dermatophytoses by clinical examination with the help of 4 – point Physician Global Assessment (PGA) scale |
Time duration- 6 week
follow up at 4th week and 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To assess the safety and relapse in patients with dermatophytoses receiving sertaconazole (2%) cream or luliconazole (1%) cream by clinical examination , KOH mount, and monitoring adverse drug events.
2)To assess the cost effectiveness of sertaconazole (2%) cream and luliconazole (1%) cream in patients with dermatophytoses
|
6th weeks |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "59"
Final Enrollment numbers achieved (India)="59" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/05/2017 |
| Date of Study Completion (India) |
31/08/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Thesis/Dissertation protocol- Superficial mycotic infection such as
‘Dermatophytoses’ is an extremely common infection occurring throughout the
world with a reported incidence of 20% in USA.The disease is caused by
dermatophytes belonging to genera of Trichophyton, Microsporum and Epidermophyton.
The fungal infections of the skin and its appendages are more common in
tropical countries like India due to environmental factors like heat (summer)
and humidity (monsoon).However in India, the most commonly occurring
clinical type of dermatophytoses for adults includes, tinea corporis (36-59%)
and tinea cruris (12-27%).
Imidazoles, allylamines and triazoles are most
effective agents for dermatophytoses. Topical daily antifungal therapy usually
involves imidazoles (namely, Sertaconazole and Luliconazole) and
allylamines (Terbinafine).
The
comparative effectiveness and safety of luliconazole and sertaconazole remains
unclear and well-designed head-to-head trials of newer antifungals are warranted
to establish these agents relative efficacy in treating tinea infections.So
this study is planned to compare sertaconazole with luliconazole in patients
with dermatophytoses.
complete study plan-
Day 0-Written informed consent , baseline investigation (10% KOH) and assessment of scale (PGA-Physician Global Assessment)
-Drug given (either sertaconazole 2% cream or luliconazole 1% cream)
End of treatment-baseline investigation (10% KOH) and assessment of scale (PGA-Physician Global Assessment)
After 2 weeks of end of treatment-baseline investigation (10% KOH) , assessment of scale (PGA-Physician Global Assessment),safety and cost effectiveness
|