| CTRI Number |
CTRI/2022/10/046157 [Registered on: 04/10/2022] Trial Registered Prospectively |
| Last Modified On: |
27/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"A study to compare two drugs Seratconazole versus Luliconacole for improvement of symptoms and to compare the side effects" |
|
Scientific Title of Study
|
"A comparative study to evaluate the efficacy and safety of topical Sertaconazole versus Luliconazole in the patient of mild tinea corporis at a tertiary care center" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mamatha KR |
| Designation |
Professor, Department of pharmacology |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Pharmacology, Ground floor, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra RD, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
6383240700 |
| Fax |
|
| Email |
mamthashekar67@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yuvarani R |
| Designation |
Junior Resident |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Pharmacology, First floor, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra RD, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
6383240700 |
| Fax |
|
| Email |
yuvaraniramamoorthy97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yuvarani R |
| Designation |
Junior Resident |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Pharmacology, First floor, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra RD, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
6383240700 |
| Fax |
|
| Email |
yuvaraniramamoorthy97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Victoria Hospital, OPD Building, Krishna Rajendra Market, Bengaluru Urban, Bengaluru 560002 |
|
|
Primary Sponsor
|
| Name |
Yuvarani R |
| Address |
Bangalore Medical College and Research Institute, Fort, Krishna Rajendra Rd, Bangalore 560002 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Yuvarani R |
Victoria Hospital |
Department of
Dermatology, Second
floor, OPD building,
Fort, Krishna Rajendra
Rd, Bengaluru,
Karnataka 560002
Bangalore
KARNATAKA |
6383240700
yuvaraniramamoorthy97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore medical College and research Institute Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, (2) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Topical Luliconazole 1% cream BD |
Duration: 6 weeks. The patient will be instructed to take a sufficient quantity of topical cream to cover/smear the affected area including 1cm of normal skin around the lesion margin both morning and night. The method of application is from the periphery to the center. |
| Intervention |
Topical Sertaconazole 2% cream BD |
Duration: 6 weeks. The patient will be instructed to take a sufficient quantity of topical cream to cover/smear the affected area including 1cm of normal skin around the lesion margin both morning and night. The method of application is from the periphery to the center. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to give written informed consent and willing for follow up
2. Patients of either gender, aged 18- 60 years
3. Patients with mild tinea corporis lesions (<3% of body surface area)3
confined to limbs and trunk with only KOH mount report positive and
treatment-naive. |
|
| ExclusionCriteria |
| Details |
1. Patients not willing to give informed consent and not willing for follow up
2. Patients with deep fungal infections
3. Patients with tinea infection on other parts of the body (scalp, groin, feet,
nails, hands, and toes )
4. Cases of dermatophytosis with a secondary bacterial infection
5. Diabetic and immuno-compromised patients
6. Pregnant and lactating mothers
7. Patients with a history of hypersensitivity to azole and allylamine groups
8. Patients on oral antifungal medications |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy is assessed based on clinical cure and mycological cure of tinea lesion.
A clinical cure is assessed based on symptoms and signs of tinea lesions namely
pruritis, erythema, and desquamation/scaling which are graded depending on intensity. Pruritus
by visual analogue score, Erythema by clinician’s erythema assessment score, Scaling is
assessed by the clinician’s assessment score will be recorded and analyzed at the
end of the 4th week and at the end of the 6th week.
A mycological cure will be assessed by KOH Mount at the baseline (1st visit) and
at the end of the 6th week. |
0,4,6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety is assessed by Adverse drug reactions which will be reported in CDSCO
form and severity grading will be done. |
baseline,4th week,6th week |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
10/10/2022 |
| 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="2"
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)?
Response - NO
|
|
Brief Summary
|
Topical antifungals are considered as the
first-line therapy for superficial dermatomycoses because of their efficacy and
low potential for systemic adverse effects. These drugs are available in
various formulations to facilitate penetration and improve efficacy. The different
classes of topical antifungal drugs for dermatophytosis include polyenes, azoles, and allylamine/benzylamines.
Luliconazole has an
imidazole moiety in the ketene dithioacetate structure augments its action
against filamentous fungi while maintaining the broad spectrum of antifungal activity. The other imidazole, Sertaconazole, with
its broad-spectrum antifungal activity has additional
anti-inflammatory and antipruritic effects because of which increased
compliance is seen amongst patients. Sertaconazole is reported to
have higher lipophilicity and greater retention of drug in the stratum corneum
leading to greater mycological cure and faster clinical cure rates with less relapse
rate.
In the Indian population, data on
head-to-head comparisons of these drugs
are scanty. Hence the present study is
undertaken to evaluate the efficacy and assess the safety of Sertaconazole
versus Luliconazole in patients with mild tinea corporis at our tertiary care center.
|