Comparison of Itraconazole With Itraconazole and Isotretinoin in the Treatment Duration, Safety a n d Cure Rate in Adult Patients of Tinea Corporis/ Cruris-A Randomised Controlled Trail
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2026
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2026
CompletedFirst Posted
Study publicly available on registry
June 30, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
Study Completion
Last participant's last visit for all outcomes
March 1, 2027
June 30, 2026
June 1, 2026
5 months
June 23, 2026
June 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Treatment related adverse events
8 weeks
Study Arms (2)
Oral itraconazol 200mg
ACTIVE COMPARATORParticipants 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
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Al newly diagnosed cases with typical tinea lesion involving at least 5% body surface area (BSA) with no nail/scalp/palm/sole involvement and no history of intake of any oral antifungal in the preceding 4 weeks or of a topical antifungal/steroid in the preceding 2 weeks. Presenting to the outpatient department or the emergency department of PEMH or CMH will be included in the study.
You may not qualify if:
- \. Patients with chronic liver and renal diseases. 2. Patients with ischaemic heart diseases. 3. Patients with hyperlipidemia. 4. 5. Those on chronic immunosuppressive therapy. Pregnant and lactating women and females of reproductive age. 6. Elderly patients above 75 years 7. Patient who had taken oral antifungal in the preceding 4 weeks or of a topical antifungal/steroid in the preceding 2 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PakEmirates
Rawalpindi, Punjab Province, 46000, Pakistan
Related Publications (1)
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.
PMID: 36103158RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident dermatology
Study Record Dates
First Submitted
June 23, 2026
First Posted
June 30, 2026
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
June 30, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
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.