Compare the efficacy of isotretinoin and Terbinafine combination with Terbinafine alone in the treatment of recurrent fungal infections of the skin

Phase 2

Completed

• Conditions: Recurrent Dermatophytosis Of Skin- Tinea Cruris and Corporis

• Registration Number: CTRI/2017/11/010471
• Lead Sponsor: AIIMS New Delhi

Brief Summary

Dermatophytosis is the fungal  infection of superficial  layers of the skin, hairs and nail. They are the most common infectious condition presenting to the skin out patient department. The incidence of recuurent and chronic infections are increasing now a days and many a factors are being attributed to this increase.  Few include drug resistance, bio film formation, changing environmental and working conditions, reinfection from other family members.  The most common species being identified from the lesions are also showing a changing trend from T. rubrum to other less commoner species. The incidence in india is some where around 20% of general population. Hence there is a need for exploration of alternate therapeutic agents in the treatment of this condition. recently a report was published in ijdvl, issue 5 about the use of oral isotretinoin in combination with itraconazole in the treatment of a single patient with recurrent dermatophytic infection and found to have complete cure in 4 weeks and no relapse was recorded in 6 months follow up. It was hypothesised that isotretinoin increased the epidermal turn over and lead to faster elimination of fungal spores from the skin, also tretinoin increased the skin pH and improved cell mediated immunity of the patient both of which were thought to help in the clearence of infection form the skin. hence, we plannned to conduct a study regarding the efficacy of isotretion in improving the clinical and microbiological cure rates in pateints with recurrent dermatophytosis. After careful selction of patients and after obtaining informed written consent,  they will be evaluated clinically, microbiologically and by laboratory investigatons. fungal cultures and bio film formation from the positive cultures will also be done. Then they will be randomised in to one of the two groups A and B by means of simple randomisation by computer generated random numbers and treated accordingly. group A with isotretinoin (0.5mg/kg) and terbinafine 250 mg twice daily for 4 weeks. group B with terbinafine250 mg twice daily for 4 weeks. no blinding will be done. post treatment they will be evaluated by means of clinical, microbiological and laboratory means. the side effects of the treatment will also be looked for. the patients will be followed up for a period of 3 months to look for the relapse of the disease. the proportion of cure rates and relapse rates will be assessed by means of proportion test and the results will be considered significant at 5 % level of significance.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-30
• Study Completion: 2018-07-30
• Last Update Posted: 2018-09-30

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1. Patients ≥ 18 years of age with tinea cruris and/or tinea corporis.
• 2. KOH (10%) positivity by microscopy from the lesion during the time of presentation.
• 3. Two or more episodes in one year.
• 4. Patients consenting to participate in the study.

Exclusion Criteria

• 1. Not willing to consent and follow up for the study.
• 2. Patients who have received any topical antifungal therapy within last 2 weeks or oral antifungal therapy in the previous 4 weeks.
• 3. Immunocompromised patients.
• 4. Patients with known active liver, cardiac, renal or neurological diseases or uncontrolled diabetes Mellitus.
• 5. Hypersensitivity to either isotretinoin or terbinafine.
• 6. Pregnant and lactating women.
• 7. Women desiring pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cure rates of infection both clinically and microbiologiically in both the groups	After 4 weeks/ 6 weeks of treatment and after 3 months follow up

Secondary Outcome Measures

Name	Time	Method
1) species identification	2) side effects of treatment

Trial Locations

Locations (1)

All India Institute Of Medical Sciences; 🇮🇳 East, DELHI, India

All India Institute Of Medical Sciences

🇮🇳East, DELHI, India

Dr Gridharan Senthilnathan

Principal investigator

9698747468

sgdbio2009@gmail.com