| CTRI Number |
CTRI/2026/03/105863 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparison of Two Medicated Creams (Luliconazole and Ciclopirox) for Treating Common Fungal Skin Infections |
|
Scientific Title of Study
|
Effectiveness of Luliconazole Cream Versus Ciclopirox Olamine Cream in the Management of Localized Cutaneous Dermatophytosis: A Randomized Control Trail |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sai Shiva Ram |
| Designation |
Postgraduate |
| Affiliation |
Saveetha medical college and hospital,saveetha institute of medical and technical sciences |
| Address |
Depatment of
dermatology [4th
floor],Saveetha
Medical
College,Saveetha
Nagar, Thandalam,
Chennai Bengaluru,
NH 48, Chennai, Tamil
Nadu 602105
Kancheepuram,
TAMIL NADU
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9000980253 |
| Fax |
|
| Email |
medasaishivaram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun Rajagopal |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha medical college and hospital,saveetha institute of medical and technical sciences |
| Address |
Depatment of
dermatology [4th
floor],Saveetha
Medical
College,Saveetha
Nagar, Thandalam,
Chennai Bengaluru,
NH 48, Chennai, Tamil
Nadu 602105
Kancheepuram,
TAMIL NADU
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8610424075 |
| Fax |
|
| Email |
drvarunrajagopal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sai Shiva Ram |
| Designation |
Postgraduate |
| Affiliation |
Saveetha medical college and hospital,saveetha institute of medical and technical sciences |
| Address |
Depatment of
dermatology [4th
floor],Saveetha
Medical
College,Saveetha
Nagar, Thandalam,
Chennai Bengaluru,
NH 48, Chennai, Tamil
Nadu 602105
Kancheepuram,
TAMIL NADU
TAMIL NADU
602105
India |
| Phone |
9000980253 |
| Fax |
|
| Email |
medasaishivaram@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College,Chennai
|
|
|
Primary Sponsor
|
| Name |
Sai Shiva Ram M |
| Address |
Saveetha medical college and hospital,saveetha
nagar,thandalam,chennai 602105 |
| 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 |
| Dr Sai Shiva Ram M |
saveetha medical college and hospital |
Depatment of
dermatology [4th
floor],Saveetha
Medical
College,Saveetha
Nagar, Thandalam,
Chennai Bengaluru,
NH 48, Chennai, Tamil
Nadu 602105
Kancheepuram,
TAMIL NADU
Kancheepuram
TAMIL NADU |
9000980253
medasaishivaram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| saveetha medical college and hospital instituitional 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 |
Received Ciclopirox olamine 1% cream. |
Frequency: The selected topical antifungal cream was applied twice daily.Method: Patients were taught to apply the cream directly onto the affected areas.Duration: The treatment intervention lasted for a total of 4 weeks |
| Comparator Agent |
Received Luliconazole 1% cream |
Frequency: The selected topical antifungal cream was applied twice daily.Method: Patients were taught to apply the cream directly onto the affected areas.Duration: The treatment intervention lasted for a total of 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinical Diagnosis: Patients presenting with clinical features of localized cutaneous dermatophytosis.Consent: Individuals who provided written informed consent to participate in the trial. |
|
| ExclusionCriteria |
| Details |
Pregnancy and Lactation: Patients who were currently pregnant or lactating.
Drug Allergies: Individuals with known previous allergies to either Ciclopirox olamine or Luliconazole.
Concurrent Therapy: Patients currently using systemic antifungal therapy that could interfere with the study results |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The main efficacy endpoint was a composite measure of clinical and mycological success assessed after four weeks of treatment.Clinical Efficacy (Global Assessment Score): Achievement of a score of 0 (complete resolution) on a 4-point scale evaluating four key symptoms: pruritus, erythema, induration, and scaling.Mycological Cure: Conversion to a negative mycological status, defined as the absence of dermatophyte hyphae on a 10% potassium hydroxide (KOH) mount examination. |
The main efficacy endpoint was a composite measure of clinical and mycological success assessed after four weeks of treatment.Clinical Efficacy (Global Assessment Score): Achievement of a score of 0 (complete resolution) on a 4-point scale evaluating four key symptoms: pruritus, erythema, induration, and scaling.Mycological Cure: Conversion to a negative mycological status, defined as the absence of dermatophyte hyphae on a 10% potassium hydroxide (KOH) mount examination. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety and Tolerability,Symptom-Specific Resolution,Patient-Reported Outcomes,Recurrence Patterns |
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
23/03/2026 |
| 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="0"
Months="5"
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
|
This study is a randomized controlled trial designed to compare the clinical effectiveness and safety of two topical antifungal creams, luliconazole 1 percent and ciclopirox olamine 1 percent, in patients with localized cutaneous dermatophytosis. The research was conducted at Saveetha Medical College and Hospital in Tamil Nadu, India. A total of 40 patients were randomly assigned to two groups, with 20 patients receiving ciclopirox olamine and 20 patients receiving luliconazole. Both medications were applied twice daily for a period of 4 weeks. Patients were evaluated at the start and end of the treatment based on a composite clinical score that measured itching, redness, skin thickening, and scaling. A mycological cure was confirmed using a potassium hydroxide mount examination. The results showed that both treatments led to significant clinical improvement. However, patients in the ciclopirox olamine group achieved lower mean clinical scores, indicating slightly better resolution of symptoms like redness and itching. Luliconazole showed high efficacy in reducing skin thickening. Both drugs were found to be safe and effective first line options for managing localized fungal skin infections in the current clinical setting |