Dermatophyte InfectionPhase 3NCT04880980
Comparison of Efficacy of Double Dose Oral Terbinafine Vs Itraconazole in Treatment of Dermatophyte Infections of Skin.
A Phase 3 study testing Terbinafine Pill and Itraconazole capsule in people with Dermatophyte Infection and Terbinafine Adverse Reaction, run by Pak Emirates Military Hospital at 1 site in Pakistan.
Trial summary
Study would be conducted to compare the efficacy and safety of double than usual dose oral terbinafine versus itraconazole in treatment of dermatophyte infections of skin in patient presenting at dermatology department of Pak Emirates Military Hospital, Rawalpindi, Pakistan. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Dermatophyte Infection, Terbinafine Adverse Reaction, Itraconazole Adverse Reaction
- What is being tested?
- Terbinafine Pill and Itraconazole capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2021to 15 Mar 2022
- Phase
- Phase 3
- 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 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- individuals with dermatophyte skin infection, aged 15-50 years with one or no co-morbidities.
Who cannot join
- individuals with two or more co-morbidities or known cases of chronic liver disease.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pak Emirates Military Hospital
Rawalpindi, Punjab Province, 46000
About this study
Official title: Comparison of Efficacy of Double Dose Oral Terbinafine Versus Itraconazole in Treatment of Dermatophyte Infections of Skin - A Prospective, Randomized Controlled Trial
Study would be conducted to compare the efficacy and safety of double than usual dose oral terbinafine versus itraconazole in treatment of dermatophyte infections of skin in patient presenting at dermatology department of Pak Emirates Military Hospital, Rawalpindi, Pakistan.
Read the detailed description
- Study would be a randomized controlled trial, in which 120 subjects would be randomly divided into two equal groups of 60 each.
- Each group would be prescribed double than usual dose of terbinafine(250 mg twice daily) or itraconazole(100mg twice daily) for 2 weeks initially. Treatment may be extended to 4 weeks if cure has not been achieved.
Patients will be diagnosed and followed on the basis of classical clinical features of dermatophyte infections and microscopic potassium hydro-oxide slide preparation for fungal hyphae and spores.
Liver function tests will be checked on day 0, 14 and 28. Individuals aged 15-50 years with one or no co-morbidity will be included in the study.
Study will be conducted over a period of 6-8 months.
- Being tested
- Terbinafine Pill, Itraconazole capsule
- Keywords
- double dose, oral terbinafine, oral itraconazole, dermatophyte skin infection, randomized controlled trial
- Medical subject headings
- Dermatomycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terbinafine PillDrug
Also called Lamisil
Double than usual dose of oral terbinafine pills will be used for treatment purpose in one group.
Itraconazole capsuleDrug
Also called Icon
Double than usual dose of oral itraconazole capsules will be used for treatment purpose in second group.
| Study group | Role | What they receive |
|---|---|---|
| Efficacy of double dose oral terbinafine in treatment of dermatophytic infections of skin | Active comparator | This group of participants will be given double than usual dose of oral terbinafine for the treatment of dermatophyte skin infections. Receives: Drug: Terbinafine Pill |
| Efficacy of double dose oral itraconazole in treatment of dermatophytic infections of skin | Active comparator | This group of participants will be given double than usual dose of oral itraconazole for the treatment of dermatophyte skin infections Receives: Drug: Itraconazole capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients cured by using double dose of oral terbinafine Vs itraconazole in the treatment of resistant dermatophyte skin infections as assessed by measuring pruritis, erythema and scaling .
Classical clinical features of dermatophyte skin infections (pruritis, erythema and scaling, all will be graded on a scale 0-3 i. e 0=none to 3=severe) would be noted at start of treatment after 2 weeks and then if required after 4 weeks of treatment.
Measured: 2-4 weeks
Adverse effects including effects on liver function tests of double dose oral terbinafine Vs itraconazole in the treatment of resistant dermatophyte skin infections.
Objective Assessment of adverse effects (nausea, vomiting, jaundice) as well as laboratory evaluation of liver function tests (Bilirubin umol/L, ALT U/L, ALP U/L) would be performed at start of treatment after 2 weeks and if required than after 4 weeks.
Measured: 2-4 weeks
Secondary outcomes (1)
Duration of treatment required to achieve cure from resistant dermatophyte infections.
Treatment response in form of clinical features (changes in erythema. Pruritis and scaling) and KOH fungal slide smear testing would be done after 2 weeks of treatment and if required than after 4 weeks.
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start15 Mar 2021
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatophyte InfectionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pak Emirates Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Umar Abdul Ali Qureshi, Pak Emirates Military Hospital
- Investigators
- Dr. Umar Abdul Ali Qureshi, MBBS, Principal investigator, Pak Emirates Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880980
- Sponsor's protocol ID
- PEMH Rawalpindi
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2021
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant's data will be kept confidential.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Double Dose Oral Terbinafine Versus Itraconazole in Treatment of Dermatophyte Infections of Skin - A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04880980
- Acronym / sponsor ID
- PEMH Rawalpindi
- Keywords
- double dose, oral terbinafine, oral itraconazole, dermatophyte skin infection, randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Pak Emirates Military HospitalUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 11 May 2021 (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.
Study would be conducted to compare the efficacy and safety of double than usual dose oral terbinafine versus itraconazole in treatment of dermatophyte infections of skin in patient presenting at dermatology department of Pak Emirates Military Hospital, Rawalpindi, Pakistan.
Detailed description
- Study would be a randomized controlled trial, in which 120 subjects would be randomly divided into two equal groups of 60 each.
- Each group would be prescribed double than usual dose of terbinafine(250 mg twice daily) or itraconazole(100mg twice daily) for 2 weeks initially. Treatment may be extended to 4 weeks if cure has not been achieved.
Patients will be diagnosed and followed on the basis of classical clinical features of dermatophyte infections and microscopic potassium hydro-oxide slide preparation for fungal hyphae and spores.
Liver function tests will be checked on day 0, 14 and 28. Individuals aged 15-50 years with one or no co-morbidity will be included in the study.
Study will be conducted over a period of 6-8 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Efficacy of double dose oral terbinafine in treatment of dermatophytic infections of skin | Active comparator | Drug: Terbinafine PillThis group of participants will be given double than usual dose of oral terbinafine for the treatment of dermatophyte skin infections. |
| Efficacy of double dose oral itraconazole in treatment of dermatophytic infections of skin | Active comparator | Drug: Itraconazole capsuleThis group of participants will be given double than usual dose of oral itraconazole for the treatment of dermatophyte skin infections |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- individuals with dermatophyte skin infection, aged 15-50 years with one or no co-morbidities.
Key exclusion criteria (1 listed)
- individuals with two or more co-morbidities or known cases of chronic liver disease.
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 |
|---|---|---|
| Terbinafine PillAlso: LamisilDouble than usual dose of oral terbinafine pills will be used for treatment purpose in one group. | Drug | Efficacy of double dose oral terbinafine in treatment of dermatophytic infections of skin |
| Itraconazole capsuleAlso: IconDouble than usual dose of oral itraconazole capsules will be used for treatment purpose in second group. | Drug | Efficacy of double dose oral itraconazole in treatment of dermatophytic infections of skin |
Primary outcome
Percentage of patients cured by using double dose of oral terbinafine Vs itraconazole in the treatment of resistant dermatophyte skin infections as assessed by measuring pruritis, erythema and scaling .
Time frame: 2-4 weeks
Classical clinical features of dermatophyte skin infections (pruritis, erythema and scaling, all will be graded on a scale 0-3 i. e 0=none to 3=severe) would be noted at start of treatment after 2 weeks and then if required after 4 weeks of treatment.
Adverse effects including effects on liver function tests of double dose oral terbinafine Vs itraconazole in the treatment of resistant dermatophyte skin infections.
Time frame: 2-4 weeks
Objective Assessment of adverse effects (nausea, vomiting, jaundice) as well as laboratory evaluation of liver function tests (Bilirubin umol/L, ALT U/L, ALP U/L) would be performed at start of treatment after 2 weeks and if required than after 4 weeks.
1 secondary outcome
Duration of treatment required to achieve cure from resistant dermatophyte infections.
Time frame: 2-4 weeks
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 1 Apr 2022.
- Individual participant dataSharing planned: No. Individual participant's data will be kept confidential.
Related trials for Dermatophyte Infection
Not yet recruitingObservational study
Fungal Resistance in Dermatophyte Infection
Dermatophyte Infection
Not yet recruitingPhase 2
Role of Oral Voriconazole in the Treatment of Resistant Dermatophyte Infections
Dermatophyte Infection
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.
Dr. Umar Abdul Ali Qureshi, MBBS principal investigator
Pak Emirates Military Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Terbinafine Pill and Itraconazole capsule in people with Dermatophyte Infection and Terbinafine Adverse Reaction, run by Pak Emirates Military Hospital at 1 site in Pakistan.
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 1 inclusion and 1 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 1 Apr 2022. 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 Pakistan. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of patients cured by using double dose of oral terbinafine Vs itraconazole in the treatment of resistant dermatophyte skin infections as assessed by measuring pruritis, erythema and scaling . (time frame: 2-4 weeks). 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 1 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.