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Several studies globally have assessed the efficacy of terbinafine and itraconazole in the treatment of tinea capitis, but local data in this regard is scarce. Therefore, this study was planned with the aim of assessing the difference between the therapeutic efficacy of itraconazole pulse therapy and terbinafine in children with tinea capitis.
The existing literature carries varying results between the effectiveness of itraconazole pulse therapy and continuous terbinafine therapy in treating tinea capitis, and local data in this regard is also scarce. The findings of this study would not only add to the statistics but would also help clinicians to offer a treatment modality in pediatric tinea capitis, which should have better efficacy, a low incidence of side effects, and better patient compliance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Terbinafine group | Experimental | Patients will be given terbinafine in a dose of 62.5 mg for less than 20 kg body weight, 125 mg from 20 to 40 kg, and 250 mg for more than 40 kg for a period of 4 weeks. |
|
| Itraconazole group | Experimental | Patients will receive itraconazole a dose of 5 mg/kg/day for 7 days and then 14 days off. Three such pulses will be given to the patients of this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terbinafine | Drug | Terbinafine will be given at a dose of 62.5 mg in patients with a body weight < 20 kg, 125 mg from 20 to 40 kg, and 250 mg in > 40 kg for a period of 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Fungus eradication | Treatment will be labeled efficacious if the patient will be cured clinically as well as mycologically, i.e., samples treated with KOH will show no fungal elements. | 9 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saima Aslam | Jinnah Hospital/Allama Iqbal Medical College, Lahore | Principal Investigator |
| Fahad Iqbal, FCPS | Sir Ganga Ram Hospital Lahore | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinnah Hospital/Allama Iqbal Medical College | Lahore | Punjab Province | 54700 | Pakistan |
Data can be shared on a reasonable request
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| ID | Term |
|---|---|
| D014006 | Tinea Capitis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D000077291 | Terbinafine |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Itraconazole | Drug | Itraconazole will be given at a dose of 5 mg/kg/day for 7 days and then 14 days off. Three such pulses will be given to the patients. |
|
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D012536 | Scalp Dermatoses |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |