Evaluation the efficacy & safety of increased dose & duration of oral itraconazole therapy in recurrent tinea corporis et cruris of skin : a pilot study

Completed

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

Registration Number: CTRI/2019/12/022283

Lead Sponsor: Dr Jnana Ranjan Dash

Brief Summary: **BACKGROUND**:Currently, dermatologists across India are inundated with cases of dermatophytosis presenting with unusual large lesions, ring within ring lesions, multiple site lesions (tinea cruris et corporis), and corticosteroid modified lesions, making diagnosis a difficult bet .In addition, chronicity of the disease has plagued the patients unlike any other dermatological condition in the country .The American Academy of Dermatology guidelines on the management of tinea cruris and corporis were published two decades ago. Also, the treatment recommendations in the standard textbooks of dermatology appear to have lost their relevance in the current clinical scenario . Thus, the management of dermatophytosis in India is in need of an evidence-based, experience-driven, practical approach from the experts in the field .The existing evidence is primarily based on observational cohort studies rather than randomized controlled trials (RCT). Properly designed RCTs are required to address these need gaps. There are published guidelines on tinea capitis and unguium . However, these are not applicable for the treatment of other dermatophytosis, like **tinea corporis, cruris** and pedis, in the current scenario in India.**Failure** to get a satisfactory clinical outcome with the **Standard** Dosage Regimens(**5**mg./kg./day,with maximum of 200mg./day) of Oral Itraconazole Therapy for **4**weeks. compelled us to try out the **Increased** Dosage Regimen (**10**mg./kg./day,with maximum. of 400mg./day)for **longer** duration of treatment.

**OBJECTIVES:** To evaluate the efficacy and safety of increased dose and duration of itraconazole in recurrent tinea corporis and tinea cruris.

**METHODS:** A single centre hospital based three arm, pilot randomized open label trial is planned in accordance with the declaration of Helsinki protocols. All patients will be selected based on their eligibility criteria after obtaining written informed consent to participate in the study. The study will be conducted at the Department of Dermatology, Venereology & Leprology outpatient department of Kalinga Institute of Medical Sciences, Bhubaneswar. The study duration will be one year. All the eligible patients will be randomly allocated in to three groups.Group A patients will receive oral itraconazole 400mg per day for 4weeks, group B patients will receive itraconazole 400mg per day for 8weeks.Group C patients will receive itraconazole 400mg per day for 12 weeks duration. Clinical and mycological cure rates in the three groups will be evaluated. Relapse rate in the three groups will be assessed up to 12 weeks after treatment.Adverse drug reactions if any will be recorded and monitored.SAMPLE SIZE: Total 120 eligible patients will be divided in to three groups.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 120

Inclusion Criteria

Patients of either gender with body weight â‰¥40 kg diagnosed with Tinea corporis & tinea cruris who are poor responders to the standard dosage regimen (100mg.
of oral Itraconazole therapy for 4 wks twice daily.) 2.
Patients of Tinea corporis & tinea cruris with frequent relapses after taking standard dosage regimens of oral Itraconazole for more than 6 months.
Female Patients of reproductive age group willing to follow contraceptive procedures during the study period.

Exclusion Criteria

Patient less than 12 years and more than 70 years of age/ less than 40 kg.
body weight.
Patient with any immunocompromised medical status viz.
Diabetes Mellitus, HIV Infection, Immunosuppressive therapy.
Patient suffering from any other illness like Congestive Cardiac failure and chronic kidney disease and patients with elevated liver enzymes (more than 2 times of upper limit of normal) 4.
Patients taking drugs viz.
rifampicin, phenytion, digoxin, anticoagulants, terfenadine, diseases which are contraindicated with itraconazole as co-therapy.
Any Oral or Topical Antifungal Therapy within 1 month of before the start of treatment trial 5.
Patients who are not capable enough to bear the cost of treatment & investigations ,not cooperative enough to come for follow up.
Pregnancy and Lactation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Mycological cure in group A,B and C.	every two weeks for 4 weeks , 8 weeks and 12 weeks
2.Clinical Cure: Improvement in Clinical Signs and Symptoms Investigatorâ€™s assessment to be rated on a 4-Point scale .Treatment Efficacy is measured by the Investigator using a 4-Point scale	every two weeks for 4 weeks , 8 weeks and 12 weeks
3.Safety of Treatment- Any adverse drug reactions will be noted at each visit.	every two weeks for 4 weeks , 8 weeks and 12 weeks
It will be assessed by recording Investigatorâ€™s &Patientâ€™s assessment of tolerability.	every two weeks for 4 weeks , 8 weeks and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Rate of relapse after completion of study period in each group.	twelve weeks

Trial Locations

Locations (1): Kalinga Institute of Medical Sciences Bhubaneswar
🇮🇳
Khordha, ORISSA, India
Kalinga Institute of Medical Sciences Bhubaneswar
🇮🇳Khordha, ORISSA, India
Dr Jnana Ranjan Dash
Principal investigator
9861102483
jrdash17462@gmail.com