Tinea CorporisPhase 4NCT07675239
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
A Phase 4 study testing Itraconazole (200 mg) and ISOtretinoin 20 MG in people with Tinea Corporis, run by Pak Emirates Military Hospital at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Tinea Corporis
- What is being tested?
- Itraconazole (200 mg) and ISOtretinoin 20 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2026to 1 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
PakEmirates
Rawalpindi, Punjab Province, 46000
Moizza Tahir, MBBS, +923000113959, mariafazeelkhan@gmail.com
Maria Ahmed, MBBS
About this study
Official title: Comparison of Itraconazole With Itraconazole and Isotretinoin in the Treatment Duration, Safety, and Cure Rate in Adult Patients With Tinea Corporis/Cruris: A Randomized Controlled Trial.
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.
- Conditions
- Tinea Corporis
- Being tested
- Itraconazole (200 mg), ISOtretinoin 20 MG
- Keywords
- Tinea, itraconazol, isotretinoin
- Medical subject headings
- Tinea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
ISOtretinoin 20 MGDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Itraconazole (200 mg) |
| 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. Receives: Drug: Itraconazole (200 mg); Drug: ISOtretinoin 20 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tinea CorporisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pak Emirates Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Ahmed, Pak Emirates Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675239
- Sponsor's protocol ID
- A/28/ERC/09/2026
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 36103158
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Itraconazole With Itraconazole and Isotretinoin in the Treatment Duration, Safety, and Cure Rate in Adult Patients With Tinea Corporis/Cruris: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07675239
- Acronym / sponsor ID
- A/28/ERC/09/2026
- Conditions
- Tinea Corporis
- Keywords
- Tinea, itraconazol, isotretinoin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pak Emirates Military HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 30 Jun 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral itraconazol 200mg | Active comparator | Drug: Itraconazole (200 mg)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 | Drug: Itraconazole (200 mg), Drug: ISOtretinoin 20 MGParticipants 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. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. 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
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 (200 mg)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. | Drug | Itraconazole Plus Isotretinoin, Oral itraconazol 200mg |
| ISOtretinoin 20 MGOral 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. | Drug | Itraconazole Plus Isotretinoin |
Primary outcome
Treatment Duration to Complete Cure
Time frame: 8 weeks
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.
1 secondary outcome
Treatment related adverse events
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Results publication: PubMed 36103158Khurana 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.
- Educational information on dermatophytosis and medical mycology relevant to the study background.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
Related trials for Tinea Corporis
Not yet recruitingPhase 4
Comparative Efficacy of Luliconazole and Bifonazole Combined With Itraconazole in Dermatophytosis
Tinea Corporis,Tinea Cruris,Tinea Faciei
RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
Not yet recruitingObservational study
Clinical, Dermoscopic, and Mycological Evaluations of Resistant Dermatophytosis
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RecruitingPhase 4
Comparing the Efficacy of Oral Fluconazole Versus Oral Itraconazole in Treating Resistant Tinea Corporis
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Recruiting
A Pilot Study to Evaluate the Therapeutic Efficacy of Intra-Lesional Immunotherapy in Patients Aged 10-60 Years With Recalcitrant Tinea Cruris and Corporis
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Itraconazole (200 mg) and ISOtretinoin 20 MG in people with Tinea Corporis, 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: opening soon, as of the sponsor's last update on 30 Jun 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Ahmed, MBBS (+9236666630, mariafazeelkhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Duration to Complete Cure (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07675239, which also lists 1 linked publication.
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 30 Jun 2026.