DermatophytosisCOATRDNCT07816510
Combination of Oral Antifungal Treatment for Refractory Dermatophytosis
A study testing Group A (TF group) receiving Oral Terbinafine (250 mg once daily) and Fluconazole (100 mg twice daily); 48 patients in people with Dermatophytosis, run by Chittagong Medical College at 1 site in Bangladesh.
Trial summary
Superficial dermatophytosis is no longer a simple, cutaneous fungal infection that is easily amenable to treatment. It has evolved into a chronic and recurrent, difficult-to-treat condition, which affects the patients' physical and social well-being. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatophytosis
- What is being tested?
- Group A (TF group) receiving Oral Terbinafine (250 mg once daily) and Fluconazole (100 mg twice daily); 48 patients
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Mar 2021to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with refractory dermatophytosis (patients who did not respond to routine treatment, relapsed soon after stoppage of treatment, or those having persistent dermatophytes infection)
- Patients of both sexes with age 18 years and above.
Who cannot join
- Refused to participate in the study.
- Pregnancy and lactation.
- Any history of a drug reaction or allergy to any of the four drugs,
- Any significant abnormality in complete blood counts (CBC), liver function test (LFT), renal function test (RFT) and electrocardiogram (ECG)
- Patients with comorbidities like cardiac disorder, liver disorder, renal disorder.
- Patients with an associated bacterial co-infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Oral Terbinafine in Combination With Other Oral Anti-Fungal Agents for Treatment of Refractory Dermatophytosis
Superficial dermatophytosis is no longer a simple, cutaneous fungal infection that is easily amenable to treatment. It has evolved into a chronic and recurrent, difficult-to-treat condition, which affects the patients' physical and social well-being. In recent years, the number of human diseases caused by this group of fungi has increased considerably. Recently, physicians are facing an overwhelmingly large number of chronic and recurrent dermatophytosis in volumes never encountered previously. This change in the clinical scenario with increasing frequency of treatment failures has given rise to innumerable treatment options mainly based on individual's experience, as the therapeutic regimens given in the standard textbooks have ceased to result in a good clinical response. However, there is a lack of original studies, especially in Bangladesh, depicting dermatophytosis as a huge menace both to the patient and the treating physician. Co-administration of drugs of different mechanisms of action can often be synergist through inhibition of complementary targets inside fungal cells. Terbinafine is a fungicidal drug that inhibits the enzyme squalene epoxidase, which converts squalene to lanosterol. Itraconazole, fluconazole and voriconazole are fungistatic drugs that act through the inhibition of the enzyme 14α-demethylase. Many dermatologists have started using higher doses and combination regimens of antifungals to counter the dermatophytes refractory to the conventional treatment. However, such regimens have not been validated, especially in our context. Hence, this study was designed to evaluate the commonly used systemic antifungal drugs, i.e., terbinafine, itraconazole, fluconazole and voriconazole at various doses and in combinationfor the treatment of refractory dermatophytes.The study results would guide dermatologists in their decision-making process while treating the refractory dermatophytes.
Read the detailed description
This open-label, comparative randomized clinical trial was conducted over a six-month period from March to August 2021, at the Department of Dermatology and Venereology of Chittagong Medical College Hospital. The study population comprised patients with refractory dermatophytosis attending the department during this period. Participants were conveniently screened against inclusion and exclusion criteria to identify eligible subjects, who were then randomly allocated into three treatment arms. Inclusion criteria encompassed individuals aged 18 years and above, diagnosed with refractory dermatophytosis, characterized by a lack of response to routine treatment, relapse post-treatment, or persistent infection. Exclusion criteria included unwillingness to participate, pregnancy or lactation, history of allergic reactions to the study drugs, significant abnormalities in complete blood counts (CBC), liver function tests (LFT), renal function tests (RFT), and electrocardiogram (ECG), as well as patients with comorbidities like cardiac, liver, or renal disorders, or those with bacterial co-infections. The initial sample size aimed for 50 patients per group, but due to dropouts, the final tally included 138 participants. The treatment groups were: Group A (TF group) receiving Oral Terbinafine (250 mg once daily) and Fluconazole (100 mg twice daily); Group B (TI group) receiving Oral Terbinafine (250 mg once daily) and Itraconazole (100 mg twice daily); and Group C (TV group) receiving Oral Terbinafine (250 mg once daily) combined with Voriconazole, dosed according to body weight at or over 40 kg body weight: 200 mg twice daily and below 40 Kg body weight: 100 mg twice daily. All patients were also administered antihistamines (levocetirizine and hydroxyzine) and were advised against using any other medicines, including topical agents. Patients were followed up at four and six weeks post-treatment initiation to evaluate efficacy and safety. Investigations conducted at baseline and subsequently at every second visit included CBC, LFT, RFT, and ECG. Compliance was monitored through the collection of used medicine strips and reminder communications at each visit. Patients showing less than 25% improvement at the end of four weeks were labeled as 'complete failures', excluded from the study, and provided alternative treatment. Participants with a partial response continued the same treatment for an additional two weeks. Those achieving complete cure at four weeks were monitored for recurrence at the six-week mark, and side effects experienced during the treatment were recorded. Data analysis involved inputting collected
- Conditions
- Dermatophytosis
- Being tested
- Group A (TF group) receiving Oral Terbinafine (250 mg once daily) and Fluconazole (100 mg twice daily); 48 patients
- Keywords
- Terbinafine, Fluconazole, Itraconazole, Voriconazole, Combination therapy, Refractory fungal infection
- Medical subject headings
- Tinea, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A (TF group) receiving Oral Terbinafine (250 mg once daily) and Fluconazole (100 mg twice daily); 48 patientsDrug
Also called Group B (TI group) receiving Oral Terbinafine (250 mg once daily) and Itraconazole (100 mg twice daily); 45 patients, Group C (TV group) receiving Oral Terbinafine (250 mg once daily) combined with Voriconazole, 45 patients
To compare the cure rate (complete, partial, and failure) among three groups and To observe adverse effects among three groups.
| Study group | Role | What they receive |
|---|---|---|
| Terbinafine and Fluconazole Group A | Experimental | Group A (TF group) receiving Oral Terbinafine (250 mg once daily) and Fluconazole (100 mg twice daily) Receives: Drug: Group A (TF group) receiving Oral Terbinafine (250 mg once daily) and Fluconazole (100 mg twice daily); 48 patients |
| Terbinafine and Itraconazole Group B | Experimental | Group B (TI group) receiving Oral Terbinafine (250 mg once daily) and Itraconazole (100 mg twice daily); Receives: Drug: Group A (TF group) receiving Oral Terbinafine (250 mg once daily) and Fluconazole (100 mg twice daily); 48 patients |
| Terbinafine and Voriconazole Group C | Experimental | Group C (TV group) receiving Oral Terbinafine (250 mg once daily) combined with Voriconazole, dosed according to body weight at or over 40 kg body weight: 200 mg twice daily and below 40 Kg body weight: 100 mg twice daily. Receives: Drug: Group A (TF group) receiving Oral Terbinafine (250 mg once daily) and Fluconazole (100 mg twice daily); 48 patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and Safety of Oral Terbinafine in Combination with Other Oral Anti-Fungal Agents for Treatment of Refractory Dermatophytosis
The primary outcome is safety of combination of oral antifungal agents terbinafine plus fluconazole vs terbinafine plus itraconazole vs terbinafine plus voriconazole using Visual Analog Scale by assessing Pruritus and Erythema grade '0' as complete clinical resolution of lesions
Measured: Over a six-month period from March to August 2021
EFFICACY AND SAFETY OF ORAL TERBINAFINE IN COMBINATION WITH OTHER ORAL ANTI-FUNGAL AGENTS FOR TREATMENT OF REFRACTORY DERMATOPHYTOSIS
The primary outcome is safety of combination of oral terbinafine plus fluconazole vs oral terbinafine plus itraconazole vs oral terbinafine plus voriconazole.
The primary clinical endpoint is pruritus; all other endpoints like erythema and scaling are secondary by default.
This will be assessed by comparing the occurrence of adverse events between the intervention and control groups through clinical history and physical examination at follow up visits (at 4 weeks and 6 weeks), hematology and biochemistry assessment (at 4 weeks and 6 weeks) and via case record form using Visual Analog Scale.
The primary adverse event of concern is pruritus.
Clinical cure: Pruritus, erythema and scaling grade '0', and complete clinical resolution of all lesions.
Measured: Over a six-month period from March to August 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Mar 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatophytosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The treatment groups were: Group A (TF group) receiving Oral Terbinafine (250 mg once daily) and Fluconazole (100 mg twice daily); Group B (TI group) receiving Oral Terbinafine (250 mg once daily) and Itraconazole (100 mg twice daily); and Group C (TV group) receiving Oral Terbinafine (250 mg once daily) combined with Voriconazole, dosed according to body weight at or over 40 kg body weight: 200 mg twice daily and below 40 Kg body weight: 100 mg twice daily.
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chittagong Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Rafiqul Mowla, Chittagong Medical College
- Investigators
- Muhammed Syedul Alam, MBBS, FCPS, Study director, Chittagong Medical CollegeAdam Reich, MD, PhD, Study director, Department of Dermatology and Venereology, University of Rzeszów, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816510
- Sponsor's protocol ID
- CMC/PG/2021/709
- Acronym
- COATRD
- Status last verified
- Sep 2026
- First submitted
- 4 Feb 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical study report
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Oral Terbinafine in Combination With Other Oral Anti-Fungal Agents for Treatment of Refractory Dermatophytosis
- ClinicalTrials.gov ID
- NCT07816510
- Acronym / sponsor ID
- COATRD / CMC/PG/2021/709
- Conditions
- Dermatophytosis
- Keywords
- Terbinafine, Fluconazole, Itraconazole, Voriconazole, Combination therapy, Refractory fungal infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Chittagong Medical CollegeUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Superficial dermatophytosis is no longer a simple, cutaneous fungal infection that is easily amenable to treatment. It has evolved into a chronic and recurrent, difficult-to-treat condition, which affects the patients' physical and social well-being. In recent years, the number of human diseases caused by this group of fungi has increased considerably. Recently, physicians are facing an overwhelmingly large number of chronic and recurrent dermatophytosis in volumes never encountered previously. This change in the clinical scenario with increasing frequency of treatment failures has given rise to innumerable treatment options mainly based on individual's experience, as the therapeutic regimens given in the standard textbooks have ceased to result in a good clinical response. However, there is a lack of original studies, especially in Bangladesh, depicting dermatophytosis as a huge menace both to the patient and the treating physician. Co-administration of drugs of different mechanisms of action can often be synergist through inhibition of complementary targets inside fungal cells. Terbinafine is a fungicidal drug that inhibits the enzyme squalene epoxidase, which converts squalene to lanosterol. Itraconazole, fluconazole and voriconazole are fungistatic drugs that act through the inhibition of the enzyme 14α-demethylase. Many dermatologists have started using higher doses and combination regimens of antifungals to counter the dermatophytes refractory to the conventional treatment. However, such regimens have not been validated, especially in our context. Hence, this study was designed to evaluate the commonly used systemic antifungal drugs, i.e., terbinafine, itraconazole, fluconazole and voriconazole at various doses and in combinationfor the treatment of refractory dermatophytes.The study results would guide dermatologists in their decision-making process while treating the refractory dermatophytes.
Detailed description
This open-label, comparative randomized clinical trial was conducted over a six-month period from March to August 2021, at the Department of Dermatology and Venereology of Chittagong Medical College Hospital. The study population comprised patients with refractory dermatophytosis attending the department during this period. Participants were conveniently screened against inclusion and exclusion criteria to identify eligible subjects, who were then randomly allocated into three treatment arms. Inclusion criteria encompassed individuals aged 18 years and above, diagnosed with refractory dermatophytosis, characterized by a lack of response to routine treatment, relapse post-treatment, or persistent infection. Exclusion criteria included unwillingness to participate, pregnancy or lactation, history of allergic reactions to the study drugs, significant abnormalities in complete blood counts (CBC), liver function tests (LFT), renal function tests (RFT), and electrocardiogram (ECG), as well as patients with comorbidities like cardiac, liver, or renal disorders, or those with bacterial co-infections. The initial sample size aimed for 50 patients per group, but due to dropouts, the final tally included 138 participants. The treatment groups were: Group A (TF group) receiving Oral Terbinafine (250 mg once daily) and Fluconazole (100 mg twice daily); Group B (TI group) receiving Oral Terbinafine (250 mg once daily) and Itraconazole (100 mg twice daily); and Group C (TV group) receiving Oral Terbinafine (250 mg once daily) combined with Voriconazole, dosed according to body weight at or over 40 kg body weight: 200 mg twice daily and below 40 Kg body weight: 100 mg twice daily. All patients were also administered antihistamines (levocetirizine and hydroxyzine) and were advised against using any other medicines, including topical agents. Patients were followed up at four and six weeks post-treatment initiation to evaluate efficacy and safety. Investigations conducted at baseline and subsequently at every second visit included CBC, LFT, RFT, and ECG. Compliance was monitored through the collection of used medicine strips and reminder communications at each visit. Patients showing less than 25% improvement at the end of four weeks were labeled as 'complete failures', excluded from the study, and provided alternative treatment. Participants with a partial response continued the same treatment for an additional two weeks. Those achieving complete cure at four weeks were monitored for recurrence at the six-week mark, and side effects experienced during the treatment were recorded. Data analysis involved inputting collected
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The treatment groups were: Group A (TF group) receiving Oral Terbinafine (250 mg once daily) and Fluconazole (100 mg twice daily); Group B (TI group) receiving Oral Terbinafine (250 mg once daily) and Itraconazole (100 mg twice daily); and Group C (TV group) receiving Oral Terbinafine (250 mg once daily) combined with Voriconazole, dosed according to body weight at or over 40 kg body weight: 200 mg twice daily and below 40 Kg body weight: 100 mg twice daily.
| Arm | Type | Receives |
|---|---|---|
| Terbinafine and Fluconazole Group A | Experimental | Drug: Group A (TF group) receiving Oral Terbinafine (250 mg once daily) and Fluconazole (100 mg twice daily); 48 patientsGroup A (TF group) receiving Oral Terbinafine (250 mg once daily) and Fluconazole (100 mg twice daily) |
| Terbinafine and Itraconazole Group B | Experimental | Drug: Group A (TF group) receiving Oral Terbinafine (250 mg once daily) and Fluconazole (100 mg twice daily); 48 patientsGroup B (TI group) receiving Oral Terbinafine (250 mg once daily) and Itraconazole (100 mg twice daily); |
| Terbinafine and Voriconazole Group C | Experimental | Drug: Group A (TF group) receiving Oral Terbinafine (250 mg once daily) and Fluconazole (100 mg twice daily); 48 patientsGroup C (TV group) receiving Oral Terbinafine (250 mg once daily) combined with Voriconazole, dosed according to body weight at or over 40 kg body weight: 200 mg twice daily and below 40 Kg body weight: 100 mg twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with refractory dermatophytosis (patients who did not respond to routine treatment, relapsed soon after stoppage of treatment, or those having persistent dermatophytes infection)
- Patients of both sexes with age 18 years and above.
Key exclusion criteria (6 listed)
- Refused to participate in the study.
- Pregnancy and lactation.
- Any history of a drug reaction or allergy to any of the four drugs,
- Any significant abnormality in complete blood counts (CBC), liver function test (LFT), renal function test (RFT) and electrocardiogram (ECG)
- Patients with comorbidities like cardiac disorder, liver disorder, renal disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A (TF group) receiving Oral Terbinafine (250 mg once daily) and Fluconazole (100 mg twice daily); 48 patientsAlso: Group B (TI group) receiving Oral Terbinafine (250 mg once daily) and Itraconazole (100 mg twice daily); 45 patients, Group C (TV group) receiving Oral Terbinafine (250 mg once daily) combined with Voriconazole, 45 patientsTo compare the cure rate (complete, partial, and failure) among three groups and To observe adverse effects among three groups. | Drug | Terbinafine and Fluconazole Group A, Terbinafine and Itraconazole Group B, Terbinafine and Voriconazole Group C |
Primary outcome
Efficacy and Safety of Oral Terbinafine in Combination with Other Oral Anti-Fungal Agents for Treatment of Refractory Dermatophytosis
Time frame: Over a six-month period from March to August 2021
The primary outcome is safety of combination of oral antifungal agents terbinafine plus fluconazole vs terbinafine plus itraconazole vs terbinafine plus voriconazole using Visual Analog Scale by assessing Pruritus and Erythema grade '0' as complete clinical resolution of lesions
EFFICACY AND SAFETY OF ORAL TERBINAFINE IN COMBINATION WITH OTHER ORAL ANTI-FUNGAL AGENTS FOR TREATMENT OF REFRACTORY DERMATOPHYTOSIS
Time frame: Over a six-month period from March to August 2021
The primary outcome is safety of combination of oral terbinafine plus fluconazole vs oral terbinafine plus itraconazole vs oral terbinafine plus voriconazole. The primary clinical endpoint is pruritus; all other endpoints like erythema and scaling are secondary by default. This will be assessed by comparing the occurrence of adverse events between the intervention and control groups through clinical history and physical examination at follow up visits (at 4 weeks and 6 weeks), hematology and biochemistry assessment (at 4 weeks and 6 weeks) and via case record form using Visual Analog Scale. The primary adverse event of concern is pruritus. Clinical cure: Pruritus, erythema and scaling grade '0', and complete clinical resolution of all lesions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Emergence of recalcitrant dermatophytosis in IndiaLink provided by the sponsor.
- Management of tinea corporis, tinea cruris, and tinea pedis: A comprehensive reviewLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Clinical study report
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammed Syedul Alam, MBBS, FCPS study director
Chittagong Medical College
Adam Reich, MD, PhD study director
Department of Dermatology and Venereology, University of Rzeszów, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A (TF group) receiving Oral Terbinafine (250 mg once daily) and Fluconazole (100 mg twice daily); 48 patients in people with Dermatophytosis, run by Chittagong Medical College at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy and Safety of Oral Terbinafine in Combination with Other Oral Anti-Fungal Agents for Treatment of Refractory Dermatophytosis (time frame: Over a six-month period from March to August 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.