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Tinea corporis and tinea cruris are common superficial fungal infections that have become increasingly difficult to treat because of prolonged disease duration, frequent recurrences, and suboptimal response to standard antifungal therapy. Itraconazole is widely used for the treatment of dermatophytosis; however, treatment failures and relapses remain a significant concern. Isotretinoin has been proposed as an adjuvant therapy because of its effects on epidermal differentiation, keratinization, and follicular function, which may enhance antifungal penetration and improve treatment outcomes.
This randomized controlled trial aims to compare itraconazole monotherapy with a combination of itraconazole and isotretinoin in adult patients with tinea corporis and/or tinea cruris. The study will evaluate treatment duration, cure rate, and safety profile of both regimens. The findings may provide evidence regarding the potential benefit of adding isotretinoin to conventional antifungal therapy and help optimize management strategies for adult patients with dermatophytosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral itraconazol 200mg | Active Comparator | Participants receive oral itraconazole according to the study protocol for the treatment of tinea corporis/cruris. Clinical and mycological responses are assessed during follow-up. |
|
| Itraconazole Plus Isotretinoin | Experimental | Participants receive oral itraconazole in combination with low-dose oral isotretinoin according to the study protocol for the treatment of tinea corporis/cruris. Clinical and mycological responses are assessed during follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itraconazole (200 mg) | Drug | Oral itraconazole 200 mg daily administered to adult patients with tinea corporis/cruris. Treatment is continued according to the study protocol, and participants are monitored for clinical improvement, mycological cure, adverse events, and recurrence. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Duration to Complete Cure | Treatment duration (in weeks) required to achieve complete cure, defined as complete clinical resolution of signs and symptoms of tinea corporis/cruris along with negative KOH microscopy. The outcome will be compared between the itraconazole monotherapy group and the itraconazole plus isotretinoin group. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment related adverse events | Frequency and severity of adverse events associated with treatment, including headache, abdominal pain, mucocutaneous dryness, jaundice, liver function test abnormalities, lipid profile abnormalities, and thyroid function abnormalities. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Ahmed, MBBS | Contact | +9236666630 | mariafazeelkhan@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PakEmirates | Rawalpindi | Punjab Province | 46000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36103158 | Result | Khurana A, Agarwal A, Agrawal D, Panesar S, Ghadlinge M, Sardana K, Sethia K, Malhotra S, Chauhan A, Mehta N. Effect of Different Itraconazole Dosing Regimens on Cure Rates, Treatment Duration, Safety, and Relapse Rates in Adult Patients With Tinea Corporis/Cruris: A Randomized Clinical Trial. JAMA Dermatol. 2022 Sep 14;158(11):1269-78. doi: 10.1001/jamadermatol.2022.3745. Online ahead of print. |
| Label | URL |
|---|---|
| Educational information on dermatophytosis and medical mycology relevant to the study background. | View source |
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Individual participant data (IPD) will not be shared because the study was not designed with participant-level data sharing provisions, and sharing such data may compromise participant confidentiality and privacy. Only aggregated study results will be reported and published.
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|
| ISOtretinoin 20 MG | Drug | Oral isotretinoin 20 mg daily administered in combination with oral itraconazole 200 mg daily to adult patients with tinea corporis/cruris. Participants are monitored for treatment response, mycological cure, adverse events, and recurrence according to the study protocol. |
|
| ID | Term |
|---|---|
| D014005 | Tinea |
| ID | Term |
|---|---|
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D015474 | Isotretinoin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
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