Comparing the effectiveness of terbinafine cream and ciclopirox cream alone and in combination in the treatment of ringworm (fungal infection)

Not yet recruiting

• Conditions: Dermatophytosis, unspecified,

• Registration Number: CTRI/2018/08/015305
• Lead Sponsor: Department of Dermatology

Brief Summary

Dermatophytosis is the most common form of mycoses which affects more than 25% of the world’s population. Dermatophytes include fungi belonging to the genera Trichophyton Microsporum and Epidermophyton which preferentially infect epidermal keratinized tissues. Infections are usually confined to the stratum corneum and dermal appendages, especially in the moist areas of the body, such as the regions between the toes, groin and inframammary area. Dermatophytes do not cause mortality, but they cause morbidity and are a major public health problem.

The distribution of species and the clinical characteristics vary with variable geographic localization, environmental and cultural factors. Trichophyton rubrum is the most common causative agent of dermatophytosis followed by Trichophyton mentagrophytes. Many factors including age, gender, living conditions, social class and underlying diseases like diabetes mellitus affect the frequency of infection with dermatophytes.Hot and humid climate in tropical and subtropical countries like India makes dermatophytosis a very common superficial fungal skin infection. Diagnosis of these mycoses is usually made clinically and confirmed by direct microscopy, fungal culture and identification of the species.

Various antifungal agents, both in oral and topical forms have been developed for treatment of dermatphytosis. The treatment of choice for localized tinea is topical antifungal agents, while systemic agents are used in extensive disease, follicular invasion and nail involvement.

Terbinafine is an allylamine which acts by inhibiting the squalene epoxidase enzyme in fungal cell membranes, leading to deficiency in ergosterol and accumulation of intracellular squalene. It is fungicidal and has been demonstrated to be efficacious in dermatophytosis both in its topical and oral formulation.

Ciclopirox olamine is a hydroxypyridone derivative. It is a topical fungicidal drug which has high affinity for trivalent cations such as Fe3+ and Al3+. These ions are involved in mitochondrial electron transport processes to produce energy and thus, by blocking these transports, it provokes a lack of energy production and subsequently the cell death.

In the recent years, injudicious use of combination creams/ over the counter preparations of antifungal agents with steroids for the treatment of dermatophytosis has led to an increase in treatment failure as well as relapses after conventional therapy. Topical terbinafine is considered the treatment of choice for localized tinea infections but clinical treatment failures are increasingly being reported. Topical ciclopirox olamine, which was primarily being used as nail lacquer for onychomycosis, has now become available in cream formulations for application on skin for dermatophytic infections.The present study aims at comparitive efficacy of topical 1% terbinafine hydrochloride and topical 1% ciclopirox olamine cream alone and in combination for the treatment of dermatophytosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-26
• Last Update Posted: 2018-10-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Koh positivity on direct microscopy showing septate hyphae of dermatophytosis 2.
• Body surface area less than 10%, not requiring systemic therapy 3.
• All age groups involved.

Exclusion Criteria

• Patients with co-existing dermatophytosis involving hair, nail, palms and soles 2.
• Patients who have used any antifungal drugs or steroids in the last 4 weeks 3.
• Pregnant and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All the patients will be assessed for therapeutic results by clinical evaluation and KOH examination at 3, 6 and 9 weeks of initiation of therapy. Complete resolution of lesions except residual pigmentary changes shall be regarded as clinical cure and KOH negativity shall be regarded as mycological cure.Those achieving complete cure will be followed up at 9th week to look for any relapse.	3 weeks | 6 weeks | 9 weeks

Trial Locations

Locations (1)

Goverment Medical College and Hospital, Sector 32, Chandigarh; 🇮🇳 Chandigarh, CHANDIGARH, India

Goverment Medical College and Hospital, Sector 32, Chandigarh

🇮🇳Chandigarh, CHANDIGARH, India

Dr Karan Chhabra

Principal investigator

8146748987

justkaran27@gmail.com