Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127868
Status:
COMPLETED
Last Update Posted:
2008-07-09
First Post:
2005-08-05
Brief Title:
Selenium Sulfide Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis Scalp Ringworm
Sponsor:
Chen Catherine MD
Organization:
Chen Catherine MD
Study Overview
Official Title:
A Randomized Double-Blinded Placebo-Controlled Study Observing the Efficacy of Selenium Sulfide 1 Shampoo Ketoconazole 2 Shampoo and Ciclopirox 1 Shampoo as Adjunctive Treatments for Tinea Capitis in Children
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None