An interventional study of Itraconazole + Isotretinoin and Itraconazole (ITZ) in Dermatophytosis, Trichophyton Infection and Resistant Dermatophyte Infection, sponsored by Multan Medical And Dental College. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by Multan Medical And Dental College · Not applicable, Interventional, and Treatment
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.
39 studies on the registry are indexed under Tinea; 8 are open to participants now.
This study's enrollment of 148 is above the median of 64 across 33 interventional studies indexed under Tinea.
Browse Tinea studies →Multan Medical And Dental College is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Itraconazole + Isotretinoin
Received oral itraconazole alone for the predefined treatment duration, with no additional systemic antifungal or systemic retinoid permitted during the treatment period.
Drug: Itraconazole (ITZ)
Drug pages: Itraconazole · Isotretinoin
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).
Oral itraconazole administered at the protocol-specified dose (example: 200 mg/day in divided doses) for the protocol-specified duration (example: 4-6 weeks).
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.
Time frame: 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.
Time frame: up to 8 weeks
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.
Time frame: 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.
Time frame: Up to 8 weeks
Ran from Jan 2025 to primary completion in Jul 2025, 5 months.
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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Itraconazole · Isotretinoin
Multan Medical And Dental College