| CTRI Number |
CTRI/2023/01/049161 [Registered on: 24/01/2023] Trial Registered Prospectively |
| Last Modified On: |
19/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the efficacy of emollient versus topical luliconazole (azole) in the maintenance of remission of recurrent dermatophytosis after adequate systemic treatment. |
|
Scientific Title of Study
|
A randomized study to evaluate and compare the efficacy of emollient versus topical luliconazole in the maintenance of remission of recurrent dermatophytosis after adequate systemic treatment. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yashdeep Singh Pathania |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Dermatology, AIIMS, Rajkot, Khandheri, Gujarat, India
Rajkot
GUJARAT
360110
India |
| Phone |
8894480089 |
| Fax |
|
| Email |
yashdeepsinghpathania@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashdeep Singh Pathania |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Dermatology, AIIMS, Rajkot, Khandheri, Gujarat, India
Rajkot
GUJARAT
360110
India |
| Phone |
8894480089 |
| Fax |
|
| Email |
yashdeepsinghpathania@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yashdeep Singh Pathania |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Dermatology, AIIMS, Rajkot, Khandheri, Gujarat, India
Rajkot
GUJARAT
360110
India |
| Phone |
8894480089 |
| Fax |
|
| Email |
yashdeepsinghpathania@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Rajkot |
|
|
Primary Sponsor
|
| Name |
AIIMS Rajkot |
| Address |
Khandheri, Gujarat (360110) |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Y S Pathania |
AIIMS Rajkot |
Room no. 117, Department of Dermatology, AIIMS Rajkot
Rajkot
GUJARAT |
8894480089
yashdeepsinghpathania@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,All India Institute of Medical Sciences(AIIMS), Rajkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tab/ Capsule Itraconazole Topical Luliconazole Cream
Tab L;evocetrizine |
Patients above 18 years of age with tinea infection of more than 6 months involving groins, glabrous skin fulfilling inclusion criteria will be included and will be randomized to two groups A and B. Group A will be administered adequate treatment for chronic dermatophytosis. Group A will be administered oral Tablet/ Capsule Itraconazole 100 mg two times a day along with topical luliconazole 1% cream for 6 weeks. Oral anti-histamines (levocetrizine 5mg) will be taken by patients as and when required for itching. Topical luliconazole 1% cream will be administered topically for another 6 weeks in group A The patients will be followed up 2 weekly for a period of 6 weeks to evaluate for recurrence of the disease clinically in groups A.
(Tab Itraconazole 100 twice daily for 6 weeks, topical Luliconazole 1% cream twice for 12 weeks) in group A. |
| Comparator Agent |
Tab/Cap Itraconazole, Topical Lulliconazole cream and White soft paraffin (emollient). Tab Levocetrizine 5 mg. |
Group B will be administered Tab./Cap. Itraconazole 100 twice daily for 6 weeks, Topical Luliconazole 1% cream twice daily for 6 weeks and White soft paraffin (emollient) for 6 weeks after completion of oral Itraconazole and topical luliconazole. Group B will be administered topical emollient (liquid, white paraffin) over the affected area for 6 weeks (Group B will be administered topical emollient (Soft, white paraffin) for 6 weeks). The patients will be followed up 2 weekly for a period of 6 weeks to evaluate for recurrence of the disease clinically in group B.) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Males and females >18 years of age.
2. Patients having tinea infection for more than 6 months.
3. Providing signed consent forms after understanding the written contents outlining the requirements of participating in the study.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or breastfeeding woman.
2. Patients suffering from diseases where immunosuppressants are indicated like autoimmune conditions.
3. Patients with history of heart disease especially chronic heart failure
4. Patients with concomitant other skin diseases.
5. Patients with tinea capitis.
6. Patients with abnormal liver function test
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the efficacy of emollient in the remission maintenance of recurrent dermatophytosis.(Using Physician Global Assessment score and Patient Global Assessment of Disease Status)
2. To compare the efficacy of emollient with topical luliconazole use in the remission of tinea infection.
We tend to monitor remission of disease in the form of new tinea lesions through the validated scores. |
6 weeks
The assessment of data in the follow up period will be assessed with the validated scoring system both for the physician and patient. Data collected will be statistically assessed using independent ‘T’ test. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of extended use of topical luliconazole for maintenance of remission in recurrent dermatophytosis patients.
We tend to monitor remission of disease in the form of new tinea lesions through the validated scores.
|
18 weeks
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
26/01/2023 |
| 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="4"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
preparing for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A randomized open label study with the intention to treat to be carried out in the All India Institute of Medical Sciences, Rajkot from July 2022 to December 2022 in the department of Dermatology, Venereology and Leprology. Written, informed consent will be obtained from all participants before enrolment, including agreement for publication. Patients above 18 years of age with tinea infection of more than 6 months involving groins, glabrous skin fulfilling inclusion criteria will be included and will be randomized to two groups A and B. Both groups A and B will be administered adequate treatment for chronic dermatophytosis. Both will be administered oral itraconazole 100 mg two times a day along with topical luliconazole for 6 weeks. Oral anti-histamines (levocetrizine 5mg) will be taken by patients as and when required. Topical luliconazole will be administered topically for another 6 weeks in group A and group B will be administered topical emollient (liquid, white paraffin) for 6 weeks. The patients will be followed up 2 weekly for a period of 6 weeks to evaluate for recurrence of the disease clinically in both groups |