Efficacy and Safety of Terbinafine and Itraconazole

NCT05881980 | Unknown Phase 2 DMC

• 1 other identifier: ERC-DMC/ECC/2023/81
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

There is a rise in the prevalence in recent years especially in tropical countries along with an increase in the number of treatment failures with chronic and recurrent dermatophytosis. There is a huge gap between the treatment required in the present scenario and the treatment guidelines given in the standard books. The aim of the study is to determine the effectiveness of terbinafine and itraconazole in different doses and in combination in the treatment of dermatophytosis. The study design will be a randomized parallel-group trial. Patients will be randomly divided into five parallel arms in which two of the standard drugs in recommended doses will be compared with their double doses and with a combination of both drugs. The patients will be reevaluated at 2, 4, 6, and 8 weeks of treatment (the end of therapy), using the physician Global Assessment (PGA) Scale. The cure will be considered a complete clinical resolution of the lesions. The patient's response to the treatment will be recorded. Safety and patient compliance will be recorded at each follow-up visit. Findings of observation will be recorded on a pre-prescribed and pre-tested data collection form. After collection, all data will be checked and compiled. Data will be processed and analyzed using computer software with statistical packages for social science SPSS-26. An analysis plan will be developed keeping in view the objectives of the study. The results of the continuous measurement will be presented on mean ± SD (mean-max) and results on categorical measurements will be presented in numbers (%). A p\<0.05 will be considered statistically significant. Results will be disseminated to all Dermatology departments in Bangladesh.

Conditions

Tinea Corporis; Tinea Cruris; Tinea Faciei; Dermatophytoses

Outcome Measures

Primary Outcomes (6)

• Assessment of clinical parameters (itching, erythema, and scaling)

  Patients will be evaluated for the severity of clinical parameters namely itching, erythema, and scaling using four-point scale as: 0 = none, l = mild, 2 = moderate, and 3 = severe. Erythema and scaling grade '0' and itching grade 0 or 1 will be considered as clinical cure.

  8 weeks

• Achievement of mycological cure at 2 weeks

  Dermatophytes or yeast seen on a KOH test indicates the person has a fungal infection. The health care provider scrapes the problem area of your skin using a needle or scalpel blade. The scrapings from the skin are placed on a microscope slide. Liquid containing the chemical potassium hydroxide (KOH) is added. The slide is then examined under the microscope. A KOH examination will be done at 2 weeks and will be noted as positive or negative.

  2 weeks

• Achievement of mycological cure at 4 weeks

  Dermatophytes or yeast seen on a KOH test indicates the person has a fungal infection. The health care provider scrapes the problem area of your skin using a needle or scalpel blade. The scrapings from the skin are placed on a microscope slide. Liquid containing the chemical potassium hydroxide (KOH) is added. The slide is then examined under the microscope. A KOH examination will be done at 4 weeks and will be noted as positive or negative.

  4 weeks

• Achievement of mycological cure at 6 weeks

  Dermatophytes or yeast seen on a KOH test indicates the person has a fungal infection. The health care provider scrapes the problem area of your skin using a needle or scalpel blade. The scrapings from the skin are placed on a microscope slide. Liquid containing the chemical potassium hydroxide (KOH) is added. The slide is then examined under the microscope. A KOH examination will be done at 6 weeks and will be noted as positive or negative.

  6 weeks

• Achievement of mycological cure at 8 weeks

  Dermatophytes or yeast seen on a KOH test indicates the person has a fungal infection. The health care provider scrapes the problem area of your skin using a needle or scalpel blade. The scrapings from the skin are placed on a microscope slide. Liquid containing the chemical potassium hydroxide (KOH) is added. The slide is then examined under the microscope. A KOH examination will be done at 8 weeks and will be noted as positive or negative.

  8 weeks

• Assessment of overall clinical symptoms with PGA

  The physician's global improvement(PGA) scale: The global improvement will be graded as grade I (1-25%), grade II (26-50%), grade III (51-75%), and grade IV (76-100%) improvement in overall clinical symptoms at the end of therapy at 8week.

  At 8 weeks

Secondary Outcomes (2)

• Assessment of treatment failure

  8 weeks

• Patient's Satisfaction with treatment

  8 weeks

Study Arms (5)

Group T1

EXPERIMENTAL

Terbinafine 250 mg/day will be given in this group

Drug: Terbinafine Tablets

Group I1

EXPERIMENTAL

Itraconazole 200 mg/day will be given in this group

Drug: Itraconazole

Group T+I

EXPERIMENTAL

Terbinafine 250 mg + Itraconazole 200 mg/day will be given in this group

Drug: Terbinafine Tablets; Drug: Itraconazole

Group T2

EXPERIMENTAL

Terbinafine 500 mg/day in two divided doses will be given in this group

Drug: Terbinafine Tablets

Group I2

EXPERIMENTAL

Itraconazole 400 mg/day in two divided doses will be given in this group

Drug: Itraconazole

Interventions

Terbinafine Tablets DRUG

Terbinafine 250 mg/day

Also known as: Terbinafine 250

Group T+I; Group T1; Group T2

Itraconazole DRUG

Itraconazole 200 mg/day

Also known as: Itraconazole 200

Group I1; Group I2; Group T+I

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical suspicion of tinea corporis, tinea cruris or tinea faciei or any combination of these conditions
• Microscopic confirmation of tinea (KOH microscopy showing regularly septate branching hyphae),
• Age 18- 60 years

You may not qualify if:

• Children less than 18 years of age
• Pregnancy and lactation
• Patients with co-existent tinea unguium, tinea pedis, or tinea manuum,
• History of recent use of antifungal drugs or steroids in last 4 weeks.
• Patient with any other disease requiring systemic therapy
• Patients with co-morbidities like cardiac disorder, liver disorder, renal disorder
• History of a drug reaction or allergy to any of the two drugs
• Any significant abnormality in complete blood counts (CBC), liver function test (LFT), renal function test (RFT), and electrocardiogram (ECG),
• Patients or attendants refused to give informed consent to take part in the study

Sponsors & Collaborators

• Dhaka Medical College: lead

MeSH Terms

Conditions

Tinea; Tinea Cruris

Interventions

Terbinafine; Itraconazole

Condition Hierarchy (Ancestors)

Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Intertrigo; Dermatitis; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Central Study Contacts

Dr. Afsana Nahid

CONTACT

01716908871; afsanaderma@dmc.gov.bd

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 31, 2023
• Study Start: May 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share