Health Condition 1: B354- Tinea corporis Health Condition 2: B356- Tinea cruris
Conditions
Interventions
None listed
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Localized infection Newly clinically diagnosed cases of localized tinea cruris (Single or less than equal to 3 well defined lesions limited to one groin or inner thigh region, less than 5 percent body surface area involvement, no extension to adjacent area) with confirmation of tinea infection through KOH microscopic examination Newly clinically diagnosed cases of localized tinea corporis (Single or less than equal to 3 well defined lesions limited to arm or trunk, less than 5 percent body surface area involvement, no extension to adjacent area) with confirmation of tinea infection through KOH microscopic examination Skin lesions of less than 4 weeks of duration Extensive infection Newly clinically diagnosed cases of extensive tinea cruris (more than equal to 3 or multiple confluent lesions involving both groins/thighs; more than or equal to 5 percent body surface area involvement, extending to adjacent areas like perineum, buttocks, abdomen, or genitals) with confirmation of tinea infection through KOH microscopic examination. Newly clinically diagnosed cases of extensive tinea corporis (more than or equal to 3 or multiple confluent lesions involving multiple non-contiguous regions (e.g., trunk, limbs); more than or equal to 5 percent body surface area involvement, widespread bilateral involvement) with confirmation of tinea infection through KOH microscopic examination. For Both Aged 18 to 65 years of either gender Willingness to receive any kind of intervention Willing to provide written informed consent. Ability to comply with study procedures.
Exclusion criteria
Exclusion criteria: Extensive infection Prolonged QTc interval on ECG during screening For both Tinea Capitis, Pedis and tinea unguium Use of systemic or topical antifungal treatment within 2 weeks before enrolment. Known hypersensitivity to any component of the study medication. Known causes for immunocompromised conditions such as HIV, Cancer, organ transplant, Chronic systemic corticosteroid therapy, etc. Participation in another clinical trial within the last 30 days. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving complete Clinical cure rate at 2 and 4 weeks for localized infection and at 4, 6, and 8 weeks for extensive infection, defined as the complete resolution of signs and symptoms of tinea infection along with a score of 0 in each symptom category of the Tinea symptoms severity score.Timepoint: 2 and 4 weeks for localized infection 4, 6, and 8 weeks for extensive infection | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with Mycological cure at 2 and 4 weeks for localized tinea, defined as a negative KOH test. o Proportion of participants with Mycological cure at 6 and 8 weeks for extensive tinea, defined as a negative KOH test. o Patient-reported outcomes using a standardized questionnaire. o Safety and tolerability assessed by the incidence of adverse events.Timepoint: 2 and 4 weeks for localized tinea 6 and 8 weeks for extensive tinea | — |
Countries
India
Contacts
Public ContactDr RK Joshi
ICMR National Institute of Traditional Medicine
Outcome results
None listed