Comparison of Combination of Itraconazole and Isotretinoin Versus Itraconazole Alone in the Treatment of Resistant Trichophyton Infection

February 12, 2026 updated by: Saba Amin, Multan Medical And Dental College

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Multan, Punjab Province, Pakistan, 60000
        • Multan Medical and Dental College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (Itraconazole + Isotretinoin)
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

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).
Active Comparator: Group B (Itraconazole Monotherapy)
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)
Oral itraconazole administered at the protocol-specified dose (example: 200 mg/day in divided doses) for the protocol-specified duration (example: 4-6 weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 8 weeks
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.
up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to symptom resolution
Time Frame: Up to 8 weeks
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.
Up to 8 weeks
Relapse (recurrence) within follow-up
Time Frame: Up to 8 weeks
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.
Up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Multan Medical And Dental College

Investigators

  • Principal Investigator: Saba Amin, Multan Medical and Dental College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2025

Primary Completion (Actual)

July 28, 2025

Study Completion (Actual)

July 28, 2025

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMDC2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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