Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07420894
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07420894
Study Brief:
Protocol Section:
NCT07420894