Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)
Condition: Tinea Capitis
MeSH terms: Tinea; Tinea Capitis
Study type: Interventional

Summary: 
      Antifungal shampoos have been used as supplements to oral griseofulvin to help eradicate
      tinea capitis (also known as ringworm of the scalp) more quickly. While selenium sulfide
      shampoo has been the gold standard, its strong odor and its drying effect on the scalp
      discourage many patients from using it. Meanwhile, no other antifungal shampoo has been
      rigorously evaluated for efficacy. Therefore, while physicians are prescribing griseofulvin
      accompanied by any of a number of antifungal shampoos for tinea capitis, it is not known
      which antifungal shampoos (excluding selenium sulfide) actually significantly reduce time to
      cure, nor which do so the fastest.

      Scalp ringworm can also re-occur in the same child. To date, no studies have been done to
      find out whether or not the use of antifungal shampoos can prevent the recurrence of scalp
      ringworm.

      In this study, children ages 1-12 years old, who have clinically diagnosed tinea capitis,
      will all be prescribed oral griseofulvin for 8 weeks. In addition, they will be randomly
      assigned to use either selenium sulfide shampoo, ketoconazole shampoo, ciclopirox shampoo, or
      baby shampoo twice a week for 8 weeks. After 8 weeks, griseofulvin will be stopped. All
      patients will continue using the same assigned shampoo twice weekly for 24 weeks, while
      continuing to return to clinic every 4 weeks for scalp evaluation.
    

Detailed description: 
      Antifungal shampoos have been used as supplements to oral griseofulvin to help eradicate
      tinea capitis (also known as ringworm of the scalp) more quickly. While selenium sulfide
      shampoo has been the gold standard, its strong odor and its drying effect on the scalp
      discourage many patients from using it. Meanwhile, no other antifungal shampoo has been
      rigorously evaluated for efficacy. Therefore, while physicians are prescribing griseofulvin
      accompanied by any of a number of antifungal shampoos for tinea capitis, it is not known
      which antifungal shampoos (excluding selenium sulfide) actually significantly reduce time to
      cure, nor which do so the fastest.

      Scalp ringworm can also re-occur in the same child. To date, no studies have been done to
      find out whether or not the use of antifungal shampoos can prevent the recurrence of scalp
      ringworm.

      In this study, children ages 1-12 years old, who have clinically diagnosed tinea capitis,
      will all be prescribed oral griseofulvin for 8 weeks. In addition, they will be randomly
      assigned to use either selenium sulfide shampoo, ketoconazole shampoo, ciclopirox shampoo, or
      baby shampoo twice a week for 8 weeks. After 8 weeks, griseofulvin will be stopped. All
      patients will continue using the same assigned shampoo twice weekly for 24 weeks, while
      continuing to return to clinic every 4 weeks for scalp evaluation.
    

Intervention name(s): oral griseofulvin, selenium sulfide shampoo 1%, ciclopirox shampoo , ketoconazole shampoo 2%, baby shampoo
Intervention type(s): Drug
Intervention MeSH terms: Selenium; Ketoconazole; Ciclopirox; Griseofulvin; Selenium disulfide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Tinea Capitis; Children; Pediatric; Treatment; Therapy; Adjunctive; Selenium Sulfide; Ciclopirox; Shampoo