To compare the efficacy of emollient versus topical luliconazole (azole) in the maintenance of remission of recurrent dermatophytosis after adequate systemic treatment.

Phase 3

Active, not recruiting

• Conditions: Other specified local infections of the skin and subcutaneous tissue,

• Registration Number: CTRI/2023/01/049161
• Lead Sponsor: AIIMS Rajkot

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-26
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	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.
2.To compare the efficacy of emollient with topical luliconazole use in the remission of tinea infection.	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.
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

AIIMS Rajkot; 🇮🇳 Rajkot, GUJARAT, India

AIIMS Rajkot

🇮🇳Rajkot, GUJARAT, India

Dr Y S Pathania

Principal investigator

8894480089

yashdeepsinghpathania@gmail.com