DermatophytosisNCT07420894
Comparison of Combination of Itraconazole and Isotretinoin Versus Itraconazole Alone in the Treatment of Resistant Trichophyton Infection
A study testing Itraconazole + Isotretinoin and Itraconazole (ITZ) in people with Dermatophytosis and Trichophyton Infection, run by Multan Medical And Dental College at 1 site in Pakistan.
Trial summary
Dermatophytosis caused by Trichophyton species is a common superficial fungal infection of the skin, hair, and nails. Increasing reports of persistent or recurrent disease after standard antifungal therapy have raised concern for treatment resistance and incomplete clearance of fungal elements from keratinised… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dermatophytosis, Trichophyton Infection, Resistant Dermatophyte Infection
- What is being tested?
- Itraconazole + Isotretinoin and Itraconazole (ITZ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Jan 2025to 28 Jul 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years
- Clinical features suggestive of dermatophytosis
- Laboratory-confirmed Trichophyton infection at baseline
- Provision of written informed consent
- Ability and willingness to comply with treatment, follow-up visits, and required laboratory monitoring
Who cannot join
- Negative potassium hydroxide microscopy and no culture evidence of Trichophyton infection at baseline
- Infection caused by non-Trichophyton dermatophytes on culture, or no growth on culture where culture is used for confirmation
- Use of additional systemic antifungal therapy during the treatment period (not permitted by protocol)
- Use of systemic retinoids other than study-assigned isotretinoin during the treatment period (not permitted by protocol)
- Pregnancy at baseline in women of childbearing potential, or inability or unwillingness to follow strict pregnancy avoidance requirements during and after isotretinoin therapy
- Any contraindication to itraconazole or isotretinoin, including known hypersensitivity to either drug
- Clinically significant baseline liver dysfunction or abnormal liver function tests considered unsafe for systemic itraconazole and or isotretinoin use
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Multan Medical and Dental College
Multan, Punjab Province, 60000
About this study
Dermatophytosis caused by Trichophyton species is a common superficial fungal infection of the skin, hair, and nails. Increasing reports of persistent or recurrent disease after standard antifungal therapy have raised concern for treatment resistance and incomplete clearance of fungal elements from keratinised tissues. Itraconazole is a widely used systemic antifungal for Trichophyton infection, however relapse after treatment can occur. Isotretinoin is an oral retinoid that reduces skin oil production and modifies keratinisation, and it may change the skin environment in a way that helps prevent persistence or recurrence of dermatophyte infection. This study will compare a combination regimen of oral itraconazole plus oral isotretinoin with oral itraconazole alone in adults with laboratory-confirmed Trichophyton infection.
This comparative clinical study will be conducted in the Dermatology Department of Multan Medical and Dental College and Ibn-E-Siena Hospital and Research Institute. Adults aged 18 to 65 years with clinical features suggestive of dermatophytosis will be screened, and only participants with confirmed Trichophyton infection on potassium hydroxide microscopy and or fungal culture will be enrolled. A total of 148 participants will be randomly allocated in equal numbers to one of two groups. One group will receive oral itraconazole plus low-dose oral isotretinoin for the study treatment period, and the other group will receive oral itraconazole alone at the same itraconazole dose and duration. Use of additional systemic antifungals or systemic retinoids during the treatment period will not be permitted.
The primary purpose is to determine whether adding isotretinoin to itraconazole improves treatment effectiveness and reduces recurrence. Outcomes will include clinical cure at the end of treatment, mycological cure based on negative potassium hydroxide microscopy at the end of treatment, time to symptom resolution, and relapse within the predefined follow-up period, assessed during scheduled follow-up visits. Safety will be monitored at each visit, including adverse drug reactions and laboratory testing as required. Liver function testing will be performed for all participants, lipid profile monitoring will be performed for participants receiving isotretinoin, and pregnancy testing and counselling on strict pregnancy avoidance will be provided for women of childbearing potential due to the known risk of fetal harm with isotretinoin.
- Being tested
- Itraconazole + Isotretinoin, Itraconazole (ITZ)
- Keywords
- Itraconazole, Isotretinoin, Chronic recurrent dermatophytosis, Recalcitrant tinea infection, Trichophyton rubrum
- Medical subject headings
- Tinea, Trichophyton infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itraconazole + IsotretinoinDrug
Oral itraconazole administered at the protocol-specified dose (example: 200 mg/day in divided doses) for the protocol-specified duration (example: 4-6 weeks).
Low dose oral isotretinoin administered at the protocol-specified dose (example: 10-20 mg/day or weight-based low dose) for the protocol-specified duration (example: 4-6 weeks).
Itraconazole (ITZ)Drug
Oral itraconazole administered at the protocol-specified dose (example: 200 mg/day in divided doses) for the protocol-specified duration (example: 4-6 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Group A (Itraconazole + Isotretinoin) | Experimental | Received oral itraconazole plus low dose oral isotretinoin for the predefined treatment duration, with no additional systemic antifungal or systemic retinoid permitted during the treatment period. Receives: Drug: Itraconazole + Isotretinoin |
| Group B (Itraconazole Monotherapy) | Active comparator | Received oral itraconazole alone for the predefined treatment duration, with no additional systemic antifungal or systemic retinoid permitted during the treatment period. Receives: Drug: Itraconazole (ITZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure
Proportion of participants with complete resolution of clinical signs and symptoms of dermatophytosis, defined as absence of active erythema, scaling, pruritus, and advancing lesion margin on clinical examination using a structured assessment proforma.
Measured: Up to 8 weeks
Mycological cure
Proportion of participants with negative potassium hydroxide microscopy from the previously involved site at the end of treatment. Where culture is performed at follow-up, mycological cure additionally requires negative fungal culture.
Measured: up to 8 weeks
Secondary outcomes (2)
Time to symptom resolution
Number of days from initiation of treatment to complete disappearance of pruritus and cessation of lesion expansion, documented on follow-up assessment and or participant diary, and confirmed on clinical review.
Measured: Up to 8 weeks
Relapse (recurrence) within follow-up
Proportion of participants with reappearance of dermatophytosis lesions at the same or contiguous site after achievement of clinical cure, within the follow-up period, with potassium hydroxide positivity where feasible.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start29 Jan 2025
- Primary completion28 Jul 2025
- Study completion28 Jul 2025
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Multan Medical And Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saba Amin, Multan Medical And Dental College
- Investigators
- Saba Amin, Principal investigator, Multan Medical And Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420894
- Sponsor's protocol ID
- MMDC2
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Combination of Itraconazole and Isotretinoin Versus Itraconazole Alone in the Treatment of Resistant Trichophyton Infection
- ClinicalTrials.gov ID
- NCT07420894
- Acronym / sponsor ID
- MMDC2
- Keywords
- Itraconazole, Isotretinoin, Chronic recurrent dermatophytosis, Recalcitrant tinea infection, Trichophyton rubrum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Multan Medical And Dental CollegeUniversity, hospital or other
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 19 Feb 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.
Dermatophytosis caused by Trichophyton species is a common superficial fungal infection of the skin, hair, and nails. Increasing reports of persistent or recurrent disease after standard antifungal therapy have raised concern for treatment resistance and incomplete clearance of fungal elements from keratinised tissues. Itraconazole is a widely used systemic antifungal for Trichophyton infection, however relapse after treatment can occur. Isotretinoin is an oral retinoid that reduces skin oil production and modifies keratinisation, and it may change the skin environment in a way that helps prevent persistence or recurrence of dermatophyte infection. This study will compare a combination regimen of oral itraconazole plus oral isotretinoin with oral itraconazole alone in adults with laboratory-confirmed Trichophyton infection.
This comparative clinical study will be conducted in the Dermatology Department of Multan Medical and Dental College and Ibn-E-Siena Hospital and Research Institute. Adults aged 18 to 65 years with clinical features suggestive of dermatophytosis will be screened, and only participants with confirmed Trichophyton infection on potassium hydroxide microscopy and or fungal culture will be enrolled. A total of 148 participants will be randomly allocated in equal numbers to one of two groups. One group will receive oral itraconazole plus low-dose oral isotretinoin for the study treatment period, and the other group will receive oral itraconazole alone at the same itraconazole dose and duration. Use of additional systemic antifungals or systemic retinoids during the treatment period will not be permitted.
The primary purpose is to determine whether adding isotretinoin to itraconazole improves treatment effectiveness and reduces recurrence. Outcomes will include clinical cure at the end of treatment, mycological cure based on negative potassium hydroxide microscopy at the end of treatment, time to symptom resolution, and relapse within the predefined follow-up period, assessed during scheduled follow-up visits. Safety will be monitored at each visit, including adverse drug reactions and laboratory testing as required. Liver function testing will be performed for all participants, lipid profile monitoring will be performed for participants receiving isotretinoin, and pregnancy testing and counselling on strict pregnancy avoidance will be provided for women of childbearing potential due to the known risk of fetal harm with isotretinoin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Itraconazole + Isotretinoin) | Experimental | Drug: Itraconazole + IsotretinoinReceived oral itraconazole plus low dose oral isotretinoin for the predefined treatment duration, with no additional systemic antifungal or systemic retinoid permitted during the treatment period. |
| Group B (Itraconazole Monotherapy) | Active comparator | Drug: Itraconazole (ITZ)Received oral itraconazole alone for the predefined treatment duration, with no additional systemic antifungal or systemic retinoid permitted during the treatment period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 65 years
- Clinical features suggestive of dermatophytosis
- Laboratory-confirmed Trichophyton infection at baseline
- Provision of written informed consent
- Ability and willingness to comply with treatment, follow-up visits, and required laboratory monitoring
Key exclusion criteria (7 listed)
- Negative potassium hydroxide microscopy and no culture evidence of Trichophyton infection at baseline
- Infection caused by non-Trichophyton dermatophytes on culture, or no growth on culture where culture is used for confirmation
- Use of additional systemic antifungal therapy during the treatment period (not permitted by protocol)
- Use of systemic retinoids other than study-assigned isotretinoin during the treatment period (not permitted by protocol)
- Pregnancy at baseline in women of childbearing potential, or inability or unwillingness to follow strict pregnancy avoidance requirements during and after isotretinoin therapy
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 |
|---|---|---|
| Itraconazole + IsotretinoinOral itraconazole administered at the protocol-specified dose (example: 200 mg/day in divided doses) for the protocol-specified duration (example: 4-6 weeks). Low dose oral isotretinoin administered at the protocol-specified dose (example: 10-20 mg/day or weight-based low dose) for the protocol-specified duration (example: 4-6 weeks). | Drug | Group A (Itraconazole + Isotretinoin) |
| Itraconazole (ITZ)Oral itraconazole administered at the protocol-specified dose (example: 200 mg/day in divided doses) for the protocol-specified duration (example: 4-6 weeks). | Drug | Group B (Itraconazole Monotherapy) |
Primary outcome
Clinical cure
Time frame: Up to 8 weeks
Proportion of participants with complete resolution of clinical signs and symptoms of dermatophytosis, defined as absence of active erythema, scaling, pruritus, and advancing lesion margin on clinical examination using a structured assessment proforma.
Mycological cure
Time frame: up to 8 weeks
Proportion of participants with negative potassium hydroxide microscopy from the previously involved site at the end of treatment. Where culture is performed at follow-up, mycological cure additionally requires negative fungal culture.
2 secondary outcomes
Time to symptom resolution
Time frame: Up to 8 weeks
Relapse (recurrence) within follow-up
Time frame: Up to 8 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 19 Feb 2026.
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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.
Saba Amin principal investigator
Multan Medical And Dental College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Itraconazole + Isotretinoin and Itraconazole (ITZ) in people with Dermatophytosis and Trichophyton Infection, run by Multan Medical And Dental College 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 5 inclusion and 7 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 19 Feb 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 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.
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?
Clinical cure (time frame: Up to 8 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 19 Feb 2026.