| CTRI Number |
CTRI/2025/07/090086 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing topical use of 0.25% Amorolfine cream with 1% Luliconazole cream for Ringworm infection |
|
Scientific Title of Study
|
Comaparative study of efficacy and tolerability of topical therapy with 0.25% Amorolfine cream versus 1% Luliconazole cream in patients of tinea corporis: A randomized, parallel group, open-label study |
| Trial Acronym |
CALET Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shubham Nimbhorkar |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Nagpur |
| Address |
Department of Dermatology and Pharmacology, Government Medical college, Hanuman nagar,Ajni Rd, Medical Chowk, Ajni, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9356890587 |
| Fax |
|
| Email |
nimbhorkarshubz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrunalini Kalikar |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Nagpur |
| Address |
Department of Pharmacology, Government Medical college, Hanuman nagar,Ajni Rd, Medical Chowk, Ajni, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9850045375 |
| Fax |
|
| Email |
mrunalinikalikar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham Nimbhorkar |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Nagpur |
| Address |
Department of Dermatology and Pharmacology, Government Medical college, Hanuman nagar,Ajni Rd, Medical Chowk, Ajni, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9356890587 |
| Fax |
|
| Email |
nimbhorkarshubz@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Hanuman nagar,Ajni Rd, Medical Chowk, Ajni, Nagpur, Maharashtra-440003 |
|
|
Primary Sponsor
|
| Name |
Government Medical College Nagpur |
| Address |
Department of Pharmacology, Government Medical college, Hanuman nagar,Ajni Rd, Medical Chowk, Ajni, Nagpur, Maharashtra-440003 |
| 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 Shubham Nimbhorkar |
Government Medical College, Nagpur |
Room No. 41, Out Patient Department, Department of Dermatology, Government Medical College, Hanuman Nagar, Ajni Rd, Medical Chowk, Ajni, Nagpur, Maharashtra 440003
Nagpur
MAHARASHTRA |
9356890587
nimbhorkarshubz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC GMC NAGPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B354||Tinea corporis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.25% Amorolfine cream |
Drug will be given for 4 weeks in Total and follow up done after Week 2 and end of study at Week 4 |
| Comparator Agent |
1% Luliconazole cream
|
Drug will be given for 4 weeks in Total and follow up done after Week 2 and end of study at Week 4 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with clinical manifestations of tinea corporis
2)Patients of 18-70 years of age.
3)Subjects of either gender.
4)Subject willing to give written informed consent.
5)Patients having a physician global assessment (PGA) composite score of at least 5 (composite score is a combined score of all clinical signs and symptoms of tinea infection) |
|
| ExclusionCriteria |
| Details |
1)Patients having clinical diagnosis of tinea infections other than tinea corporis
2)Patients having extensive fungal infection
3)Patients who had received topical or oral antifungal agents up to 4 weeks before the initiation of the study
4)History of hypersensitivity to the study drugs
5)Patients who are known cases of compromised immune status
6)Patients having superadded bacterial infection
7)Pregnant or lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients achieving clinical improvement/cure at 4 weeks (the end of treatment period) w.r.t. Physician Global Assessment Scale(absence of signs and symptoms such as erythema, scaling, and pruritus) |
Proportion of patients showing improvement/clinical cure will be assessed at Week 2 and Week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tolerability assessment evaluated by systematically recording and assessing all spontaneously reported adverse events from participants during the 4 week treatment period |
1. Baseline (start of treatment)
2. Follow up (2 weeks after initiation)
3. End of treatment (4 weeks after initiation)
Follow-up assessments at 2 weeks and 4 weeks post-treatment to evaluate Tolerability assessment done by recording and evaluating the spontaneously reported adverse events by the participants |
| Proportion of patients showing improvement in quality of life, assessed using the Dermatology Life Quality Index (DLQI) questionnaire. |
The DLQI questionnaire will be filled by the patient at the following time points:
1.Baseline (start of treatment)
2. End of treatment (after 4 weeks from initiation) |
|
|
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)
|
02/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1.Title of the study: Comparative study of efficacy and tolerability of topical therapy with 0.25% Amorolfine cream versus 1%luliconazole cream in patients of tinea corporis A randomized parallel group open label study
2.Introduction: Dermatophytosis is a common superficial fungal infection caused by keratinophilic fungi primarily affecting keratinized tissues like skin hair and nails It is most prevalent in tropical and subtropical countries due to hot and humid climate
3.Objective: a)Primary: To compare the efficacy of 0.25% Amorolfine cream and 1% luliconazole cream in the treatment of tinea corporis b)secondary: (i)To compare the tolerability of 0.25% Amorolfine cream and 1% luliconazole cream in the treatment of tinea corporis (ii)To compare the improvement in Dermatology Life Quality Index (DLQI) between 2 percent naftifine cream and 1 percent luliconazole cream in the treatment of tinea corporis
4.Study design: Randomized parallel group open label study
5.Study setting: Conducted at the outpatient department of Dermatology Venereology and Leprosy
6.Study population: Patients with clinically diagnosed tinea corporis meeting inclusion and exclusion criteria
7.Sample size: 90 patients
8.Intervention: Group A will receive 0.25% Amorolfine cream once daily for two weeks Group B will receive 1% luliconazole cream once daily for two weeks
9.Control group: Not applicable as both groups receive active interventions
10.Duration: Two weeks of treatment with follow up at the end of therapy and after two weeks post treatment
11.Outcomes: a)Primary outcome: Clinical and mycological cure rates at the end of therapy
b)Secondary outcomes: Adverse effects and recurrence rates at follow up
12.Data collection: Clinical assessment and mycological evaluation will be performed at baseline end of therapy and follow up
13.Statistical analysis: Data will be analyzed using appropriate statistical methods to compare efficacy and tolerability between groups
14.Ethical considerations: The study will be conducted after obtaining approval from the Institutional Ethics Committee and informed consent from all participants
15.Expected impact: The study aims to provide comparative data on the effectiveness and safety of two topical antifungal agents which may guide clinicians in selecting appropriate therapy for tinea corporis |