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| Name | Class |
|---|---|
| PAEC general hospital | OTHER_GOV |
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Pityriasis versicolor is a common superficial fungal infection caused by Malassezia species, characterized by hypo- or hyper-pigmented scaly patches on the skin. Topical antifungal agents are the mainstay of treatment. Ketoconazole has been widely used; however, newer agents such as luliconazole may offer improved efficacy and shorter treatment duration. This randomized controlled study aims to compare the efficacy and safety of topical luliconazole versus topical ketoconazole in patients with pityriasis versicolor. Treatment response will be assessed clinically and mycologically to determine comparative outcomes.
Pityriasis versicolor is a superficial fungal infection caused by Malassezia species and is commonly treated with topical antifungal agents. Ketoconazole is a conventional treatment, while luliconazole is a newer topical antifungal with potent activity against fungal organisms. This randomized controlled trial is designed to compare the clinical and mycological efficacy, safety, and tolerability of topical luliconazole versus topical ketoconazole in patients diagnosed with pityriasis versicolor. Eligible participants will be randomly allocated into two treatment groups and followed for treatment response and adverse effects. The findings of this study may help determine a more effective topical treatment option for pityriasis versicolor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Luliconazole 1% cream | Experimental | Participants will receive topical luliconazole 1% cream applied once daily to affected areas for the treatment of pityriasis versicolor. |
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| Topical ketoconazole 2% cream | Experimental | Participants will receive topical ketoconazole 2% cream applied twice daily to affected areas for the treatment of pityriasis versicolor. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luliconazole Cream 1% | Drug | Ketoconazole is relatively hydrophilic with limited skin retention, whereas luliconazole is highly lipophilic, resulting in superior stratum corneum penetration, higher keratin binding, and prolonged antifungal activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical and mycological cure rate in pityriasis versicolor. | Proportion of participants achieving both clinical and mycological cure. | 4 weeks |
| Clinical and mycological cure | Proportion of participants achieving both clinical and mycological cure | 4 weeks after completion of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sana Rafique, MBBS | Contact | +923355956563 | sanafmdc@gmail.com |
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| Label | URL |
|---|---|
| Related Info | View source |
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Individual participant data from this study will not be shared, as it is a small, single center based study. aggregate forms will be used to analyze the results. To ensure patients confidentiality data sharing is limited. Beyond the stated study object the dataset will not be used for any secondary purpose.
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Participants will be randomly assigned into two parallel groups. One group will receive topical luliconazole, while the other group will receive topical ketoconazole for the treatment of pityriasis versicolor. Clinical and mycological outcomes will be compared between the two groups.
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This is an open-label study; no participants, care providers, investigators, or outcome assessors are masked.
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| Topical ketoconazole 2% cream | Drug | Ketoconazole is relatively hydrophilic with limited skin retention, whereas luliconazole is highly lipophilic, resulting in superior stratum corneum penetration, higher keratin binding, and prolonged antifungal activity. |
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| ID | Term |
|---|---|
| D014010 | Tinea Versicolor |
| ID | Term |
|---|---|
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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